May 16, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

Size: px
Start display at page:

Download "May 16, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852"

Transcription

1 701 Pennsylvania Avenue, NW Suite 800 Washington, D.C Tel: Fax: May 16, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD RE: Docket No. FDA 2013 N 0745: Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments Dear Sir or Madam: On behalf of AdvaMed, the Advanced Medical Technology Association, we are pleased to submit these comments in response to the Food and Drug Administration s (FDA) request for comments on the issues and challenges associated with the collection, analysis and availability of demographic subgroup data in FDA applications. The Advanced Medical Technology Association (AdvaMed) is the world s largest trade association representing medical device and diagnostics manufacturers. AdvaMed's member companies produce the innovations that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed has more than 400 member companies, ranging from the largest to the smallest medical technology innovators and manufacturers. AdvaMed advocates for a legal, regulatory and economic environment that advances global health care by assuring worldwide patient access to the benefits of medical technology. The Association promotes policies that foster the highest ethical standards, rapid product approvals, appropriate reimbursement, and access to international markets. AdvaMed supports the collection, analysis and communication of demographic subgroup information by sex, age, race and ethnicity. We agree with a number of key findings in the FDA Report on the Collection, Analysis and Availability of Demographic Subgroup Data for FDA- Approved Medical Products with respect to medical devices including that: Many Premarket Approval Applications (PMAs) ( nearly one quarter ) include an additional pivotal study cohort to obtain clinical experience in a specific subpopulation. Demographic subgroups may vary by product area because a variety of factors may influence the interpretation and clinical relevance of demographic information including the intended population for use, the disease prevalence and the study sample size. Bringing innovation to patient care worldwide

2 Division of Dockets Management (HFA-305) May 16, 2014 Page 2 of 7 The unique nature of medical devices may mean that additional information on demographic subgroups may not be contributory to FDA decision-making (e.g., additional analyses by subpopulations may be unnecessary when the in vitro diagnostic test s analyte detection and performance are highly accurate.) 1 AdvaMed provides responses to the questions in the Federal Register below. A. Demographic Subgroup Representation in Clinical Trials 1. What approaches might be used to encourage enrollment of representative proportions of subgroup participants in clinical trials consistent with disease prevalence in the underlying population being studied? Although FDA does not indicate it will require enrollment of representative proportions of subgroup participants in clinical trials consistent with disease prevalence, AdvaMed cautions FDA in taking such an approach, particularly for medical device trials. As we indicated in our March 19, 2012 comments on the Draft Guidance for Industry and Food and Drug Administration Staff: Evaluation of Sex Differences in Medical Device Clinical Studies, FDA should not require sponsors to enroll specific percentages of subgroups consistent with disease prevalence unless there is evidence that a difference in outcomes is anticipated for the subgroup. We also commented that FDA should provide guidance as to when FDA would require collection of further data to assure there are no meaningful/significant differences in device performance when a non-significant trend develops by chance. We urged this approach in our comments on the draft guidance and we also urge them for these comments because many devices are designed for the human anatomy which shares anatomical features across all sub-groups, including male and female populations (except where there are individual congenital deficiencies), and are designed to replace or augment a function of the body and typically act locally. As an example, for many devices, the most important subgroup may be anatomical size or BMI. It is also important to note that females and racial and ethnic minorities face significant and well-documented barriers that prevent them from receiving guideline indicated devices such as stents, ICDs, and CRTDs. The medical device industry, government agencies, physician societies and advocacy groups have focused on improving access to these populations. However, gaps in device utilization still persist. The FDA should consider the current utilization of these therapies in subpopulation rather than prevalence when encouraging enrollment of subgroup participants. It is also important to recognize that most device studies are not large enough to include substantial representations of small demographic subgroups. Requiring disease prevalence representation (if validated evidence can be found to calculate disease prevalence by subgroup) will likely considerably lengthen the trial time to enrollment and substantially increase trial costs as more trial sites will need to be established in order to shorten recruitment time. It may also not be easy to define what is considered as 1 FDA Report on Collection, Analysis, and Availability of Demographic Subgroup Data for FDA- Approved Medical Products, August p

3 Division of Dockets Management (HFA-305) May 16, 2014 Page 3 of 7 consistent with disease prevalence. A requirement for demographic subgroup disease prevalence representation will depress medical device innovation over time. In lieu of required demographic subgroup disease prevalence representation in device trials, AdvaMed recommends that sponsors clinical trial plans include recruitment of diverse human subjects consistent with the Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. In general demographic subgroup analysis should only be required as part of a clinical trial if there is prior evidence that there is an anticipated difference in patient outcomes for the demographic subgroup in question. If there is evidence of a demographic subgroup difference, sponsors could be encouraged to choose clinical trial sites that may have an overrepresentation of the demographic group in question, develop subject specific study materials, or work with relevant patient advocacy groups as some examples. If evidence of demographic subgroup differences develop during the trial, a postmarket study could be developed to assess whether the difference is significant or is by chance. In addition, to encourage enrollment of demographic subgroups, some sponsors have instituted therapy awareness groups to work within the communities of those likely to receive their product. These groups work to assure adequate understanding of the disease and device as well as access to therapy and to assure that appropriate follow-up exists across all demographic segments that receive the product. Development of trust within the research environment is essential to encourage subject participation in a clinical trial. 2. What sources could be used to define disease prevalence among subgroups? Are there priority areas for study in terms of disease/condition, or in terms of demographic subgroup? It is not clear that disease prevalence exists for all device types and their related diseases and conditions. However, peer-reviewed journals and the Centers for Disease Control (CDC) may have some information on disease prevalence for certain diseases and conditions. CMS claims data or provider data bases (private payer) may also enable racial or ethnic prevalence to be established for certain diseases or conditions. The National Institutes of Health and state public health departments may also have relevant databases. Leading clinicians in a particular field, may also be aware of disease prevalence information, particularly for rare or small demographic subgroups (e.g., pediatric subgroups). In some instances, obtaining disease prevalence information would be a clinical trial in itself. 3. What are best practices and considerations for developing inclusion and exclusion criteria for clinical trials generally and for the early stages of research? The first consideration for clinical trials generally is the trial sponsor s understanding of the disease and/or condition. One should be aware of the breakdown (whenever possible) by gender, race, age, comorbidities, BMI, or the related key medical/demographic factors for that disease or condition. Particularly for late phase trials, the population being

4 Division of Dockets Management (HFA-305) May 16, 2014 Page 4 of 7 recruited for the medical device trial should reasonably represent the intent-totreat/intent-to-diagnose population upon commercialization. There are times when a sponsor may decide to initially target a subpopulation likely to have lower risk and/or higher benefit from the device. For instance, one might initially exclude patients near the end stage of disease (in the protocol exclusion criteria and from labeling) and first study earlier stage disease patients to assure success in efficacy there and only later conduct a separate trial with late stage disease patients so as to extend the labeling to the later stage disease population. This may be done to de-risk the development program associated with the more challenging-to-successfully-treat subpopulations and to protect them when the benefit may not outweigh the risk of the use of the device. The sponsor must take into consideration whether labeling restrictions may result from excluding key populations. For devices, early feasibility studies often purposely target subpopulations based on disease state and condition with a preference toward more robust patients and/or those more likely to demonstrate efficacy. Again, this is done to generate clinical trial data as early as possible and to give the manufacturer reason to believe that further clinical study will lead to a product that adds value to the health care system. It also protects vulnerable, higher risk subpopulations when there are concerns or uncertainty regarding the device safety profile. 4. What approaches should FDA use to standardize the capture of race and ethnicity information, including for studies conducted outside the United States? Standardization may be an impossible task, given all the mixed racial and ethnic identities around the world. Ideally, one would know the genetics of each subject, and their resulting propensity to the outcomes being measured. However, this remains a long-term objective at present, particularly when one considers the complex interplay between an individual s genetics and the culture/environment within which the patient resides factors which may determine the outcome of an illness in a given patient. FDA could ask sponsors to take into consideration the most relevant racial or ethnic considerations for that disease state, trial and test device. FDA could also consider whether it s Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials should be updated. Based on input from AdvaMed members, a current and growing challenge is how to handle mixed races/ethnicities in clinical trials. If FDA updates its guidance, it should provide recommendations on this growing issue. One caveat or limitation that FDA should take into account is that current practices due to privacy laws in some OUS areas (e.g., European Union) may limit the ability to collect demographic subgroup data. B. Analysis of Demographic Subgroup Data 1. What are the statistical challenges in analyzing clinical trial data to evaluate subgroup differences?

5 Division of Dockets Management (HFA-305) May 16, 2014 Page 5 of 7 The statistical challenges for powering a subgroup (when it is appropriate due to prior meaningful differences in clinical outcomes) are similar to the statistical challenges associated with primary populations: one must enroll sufficient subjects to obtain statistical power and to understand event rates. Assumptions regarding equivalent intervention effects and variance between the overall population and the subgroups are not always tenable, and it is important to delineate whether the subgroup analyses are being performed for specific labeling indications or for a due diligence check on unusual or unexpected results in a specific subgroup (see response to B.2. below). Additionally, the reduced subgroup sample size brings a concurrent loss of power and precision for the planned statistical inference whether it is formal hypothesis testing or confidence interval estimation. 2. Given that it is not feasible to power most studies to detect subpopulation differences, what approaches should be used to analyze subgroups to explore clinically relevant information? Appropriate statistical analysis for some demographic subgroups might require doubling, tripling or quadrupling sample sizes with concurrent increases in the time and cost of a trial a logistical and financial hurdle that could prevent many device trials from being undertaken. In cases where labeling indications are sought for a specific subgroup, then we support appropriate statistical powering of the study to establish the subgroup effect in a way that protects the overall Type I error planned for the study. In due diligence cases, where subgroups are being investigated for consistency of results with the overall population to rule out an unexpected result, the planned statistical analyses of effectiveness should include a separate analysis where the effect of the subgroups are examined by means of an interaction term and graphical displays of the results by subgroup. The goal here would be to demonstrate consistency in the effect of intervention, and to identify or rule out a possible qualitative interaction across the levels of the subgroup variable (i.e., results in opposite directions across subgroup levels). From a safety perspective, similar graphical presentations could be provided for key complications or safety parameters to establish consistency in intervention effect across subgroups. 3. How might additional clinically relevant information about subgroups be obtained in the postmarket setting? We concur that it will not be feasible to power most medical device studies to detect subpopulation differences. In general, if there is a demographic subgroup trend that is detected during a trial, it could be studied postmarket either through a postmarket study or, if there is an existing and appropriate registry, potentially through the registry. Discussions should occur between the sponsor and FDA to determine the most appropriate mechanism to study demographic subgroup trends to assess whether they are significant or by chance.

6 Division of Dockets Management (HFA-305) May 16, 2014 Page 6 of 7 We would also note that Medwatch forms currently contain sex and age but do not include race or ethnicity. FDA may want to consider whether revising the Medwatch forms to capture race and ethnicity might be a useful mechanism to obtain clinically relevant information about subgroups in the postmarket setting. Finally, we urge FDA not to withhold clearance or approval of products while demographic subgroup trends are being studied (assuming the clinical trial data demonstrates that the device is safe and effective for its intended use). Withholding clearance or approval, would result in the perverse situation in which devices would be withheld for some demographic subgroups (e.g., females) while studies to assess a potential demographic trend are performed (e.g., for males) to determine if it is significant or by chance for some additional period of time. C. Communication of Demographic Subgroup Information to the Public 1. What information regarding demographic subgroups is helpful to health care professionals to make informed decisions about the use of medical products? To consumers/patients? To researchers? 2. What is the best way for FDA to communicate and make accessible such information to health care professionals? To consumers/patients? To researchers? If there is a scientific basis for the belief that there will be clinically meaningful demographic subgroup difference in outcomes, the clinical trial should be designed to answer the demographic subgroup question if reasonably possible (e.g., if sufficient members of the demographic subgroup can be enrolled in the trial in a timely manner). Demographic subgroup data should only be communicated if there is a scientific basis for the information or if there is the potential for significant risk to the patient s health or well-being (e.g., a significant difference exists or a prevailing theory on safety and effectiveness in a subgroup was overturned by clinical trial findings). If a trial were not designed or powered to assess safety and effectiveness in a subgroup, no comments should be made to the public, due to the significant potential for misinterpretation. Physicians treating a patient must make judgments from imperfect information, including trial subgroup analyses. Even the data communicated to physicians should be carefully bounded to avoid misinterpretation. Information regarding demographic subgroup analyses associated with devices should be included in the product labeling for health care providers and/or patients. For clinicians, researchers and patients, the information should also be included in clinical trial results on ClinicalTrials.gov and in 510(k) Summaries and PMA Summaries of Safety and Effectiveness (SSEDs). In other testimony to the Institutes of Medicine on strategies for responsible sharing of clinical trial data, AdvaMed has recommended that FDA should make 510(k) and SSEDs more prominent on FDA s website so they can be more easily accessed by the public. In the same testimony, we also recommended that medical journals should make their articles free and accessible to the public, potentially after a

7 Division of Dockets Management (HFA-305) May 16, 2014 Page 7 of 7 period of exclusivity or within a defined timeframe after publication. Currently, accessing medical journal articles is prohibitively expensive for the general public. Finally, such information should also be included in patient brochures and publications targeting the population-at-large concerned with their health. For purposes of this particular docket, No. FDA 2013 N 0745, we would also like to resubmit the comments we provided to this docket on November 20, 2013 which provided our recommendations and comments on FDA s Action Plan on demographic subgroups. Many of the comments and recommendations are relevant for the questions in this docket. In conclusion, thank you for the opportunity to provide comments on the issues and challenges associated with the collection, analysis and availability of demographic subgroup data in FDA applications. Please don t hesitate to contact me if you have any questions. Sincerely, Tara Federici Vice President, Technology and Regulatory Affairs Enclosures

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

50

51

Re: Docket No. FDA D Presenting Risk Information in Prescription Drug and Medical Device Promotion

Re: Docket No. FDA D Presenting Risk Information in Prescription Drug and Medical Device Promotion 1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org August 25, 2009 Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane, Rm. 1061 Rockville,

More information

September 28, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

September 28, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 September 28, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. : Center for Devices and Radiological Health 510(k)

More information

Medical Devices and the Public s Health: The FDA 510(k) Clearance Process at 35 Years. Written Statement of

Medical Devices and the Public s Health: The FDA 510(k) Clearance Process at 35 Years. Written Statement of Medical Devices and the Public s Health: The FDA 510(k) Clearance Process at 35 Years Written Statement of Dr. David R. Challoner Vice President for Health Affairs, Emeritus University of Florida and Chair,

More information

July 7, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852

July 7, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852 July 7, 2012 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2012-N-0408: Risk Evaluation and Mitigation Strategy Assessments:

More information

ANDA Arthur P. Bedrosian, President Armenpharm, Ltd. 49 South Ridge Road P.O. Box D1400 Pomona, NY December 3, 2015

ANDA Arthur P. Bedrosian, President Armenpharm, Ltd. 49 South Ridge Road P.O. Box D1400 Pomona, NY December 3, 2015 DEPARTMENT OF HEALTH & HUMAN SERVICES Silver Spring, MD 20993 ANDA 060851 Arthur P. Bedrosian, President Armenpharm, Ltd. 49 South Ridge Road P.O. Box D1400 Pomona, NY 10970 Docket No. FDA-2011-P-0081

More information

Yale New Haven Health Services Corporation/Center for Outcomes Research and Evaluation (YNHHSC/CORE)

Yale New Haven Health Services Corporation/Center for Outcomes Research and Evaluation (YNHHSC/CORE) 701 Pennsylvania Avenue, Ste. 800 Washington, DC 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org July 8, 2011 Yale New Haven Health Services Corporation/Center for Outcomes Research and

More information

Facilitate physician access to compounded drugs for office-use from 503A compounding pharmacies for patients with emergent conditions;

Facilitate physician access to compounded drugs for office-use from 503A compounding pharmacies for patients with emergent conditions; By Electronic Delivery Scott Gottlieb, MD Commissioner Food and Drug Administration Attn: Division of Dockets Management (HFA-305) 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: FDA-2017-N-5093 for

More information

CMS Issues New Draft Guidance on Coverage with Evidence Development Policy for National Coverage Determinations

CMS Issues New Draft Guidance on Coverage with Evidence Development Policy for National Coverage Determinations December 6, 2012 CMS Issues New Draft Guidance on Coverage with Evidence Development Policy for National Coverage Determinations For more information, contact: Seth H. Lundy +1 202 626 2924 slundy@kslaw.com

More information

Guidance for Industry Migraine: Developing Drugs for Acute Treatment

Guidance for Industry Migraine: Developing Drugs for Acute Treatment Guidance for Industry Migraine: Developing Drugs for Acute Treatment DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft

More information

Comments of the Patient, Consumer, and Public Health Coalition. Strengthening the Center for Devices and Radiological Health s 510(k) Review Process

Comments of the Patient, Consumer, and Public Health Coalition. Strengthening the Center for Devices and Radiological Health s 510(k) Review Process March 19, 2010 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Comments of the Patient, Consumer, and Public Health Coalition on Strengthening

More information

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

The proposed rule is significant, and the requirements and exceptions are complex. Key provisions of the proposal are described below.

The proposed rule is significant, and the requirements and exceptions are complex. Key provisions of the proposal are described below. ADVISORY Food & Drug FDA ISSUES PROPOSED RULE TO ESTABLISH A UNIQUE DEVICE IDENTIFICATION SYSTEM FOR MEDICAL DEVICES July 16, 2012 On July 11, 2012, the Food and Drug Administration (FDA) published in

More information

Implementation: Public Hearing: Request for Comments (FDA-2017-N-6502)

Implementation: Public Hearing: Request for Comments (FDA-2017-N-6502) March 16, 2018 via online submission: www.regulations.gov The Honorable Scott Gottlieb Commissioner Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Opioid Policy Steering

More information

BACKGROUND + GENERAL COMMENTS

BACKGROUND + GENERAL COMMENTS Response on behalf of Sobi (Swedish Orphan Biovitrum AB) to the European Commission s Public Consultation on a Commission Notice on the Application of Articles 3, 5 and 7 of Regulation (EC) No. 141/2000

More information

Guidance for Industry

Guidance for Industry Reprinted from FDA s website by Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R1) U.S. Department

More information

Draft Guidance for Industry and FDA Staff

Draft Guidance for Industry and FDA Staff Draft Guidance for Industry and FDA Staff Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile DRAFT GUIDANCE This guidance document

More information

Submitted to: Re: Comments on CMS Proposals for Patient Condition Groups and Care Episode Groups

Submitted to: Re: Comments on CMS Proposals for Patient Condition Groups and Care Episode Groups April 24, 2017 The Honorable Seema Verma Administrator Centers for Medicare & Medicaid Services Hubert H. Humphrey Building 200 Independence Avenue SW Washington, D.C. 20201 Submitted to: macra-episode-based-cost-measures-info@acumenllc.com

More information

Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: A Workshop

Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: A Workshop Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: A Workshop Jonca Bull, MD Director, FDA Office of Minority Health The Institute of Medicine, Roundtable on

More information

June 9, U.S. Food and Drug Administration Division of Dockets Management, HFA Fishers Lane, Room 1061 Rockville, MD 20852

June 9, U.S. Food and Drug Administration Division of Dockets Management, HFA Fishers Lane, Room 1061 Rockville, MD 20852 June 9, 2014 U.S. Food and Drug Administration Division of Dockets Management, HFA-305 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Implementation of the Food and Drug Administration Food Safety

More information

510(k) submissions. Getting US FDA clearance for your device: Improving

510(k) submissions. Getting US FDA clearance for your device: Improving Getting US FDA clearance for your device: Improving 510(k) submissions Audrey Swearingen, RAC Director, Regulatory Affairs Telephone: +1 512.222.0263 Email: aswearingen@emergogroup.com Download this white

More information

Use of Standards in Substantial Equivalence Determinations

Use of Standards in Substantial Equivalence Determinations Guidance for Industry and for FDA Staff Use of Standards in Substantial Equivalence Determinations Document issued on: March 12, 2000 U.S. Department Of Health And Human Services Food and Drug Administration

More information

the May 2010 Draft Guidance on Azelaic Acid, and you request that the FDA take the following actions relating to those comments:

the May 2010 Draft Guidance on Azelaic Acid, and you request that the FDA take the following actions relating to those comments: (.t ~stltvic's. ~"~Iy"~ DEPARTMENT OF HEALTH &. HUMAN SERVICES JUN 22 2012 Food and Drug Administration Rockvile MD 20857. David L. Rosen Foley & Lardner LLP 3000 K Street, N.W., Suite 500 Washington,

More information

FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) CLINICAL SECTION CHECKLIST OFFICE OF DEVICE EVALUATION

FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) CLINICAL SECTION CHECKLIST OFFICE OF DEVICE EVALUATION FDA SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) CLINICAL SECTION CHECKLIST OFFICE OF DEVICE EVALUATION Note to FDA PMA Reviewers: The Summary of Safety and Effectiveness (SSED) is a document mandated

More information

DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials

DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials EFSPI Comments Page General Priority (H/M/L) Comment The concept to develop

More information

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development Guidance for Industry DRAFT GUIDANCE This guidance

More information

Use of Light, Mild, Low, or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products

Use of Light, Mild, Low, or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products Guidance for Industry and FDA Staff Use of Light, Mild, Low, or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products June 2010 For questions regarding this guidance, contact the

More information

Re: Docket No. FDA-2009-N-0294 Regulation of Tobacco Products; Request for Comments

Re: Docket No. FDA-2009-N-0294 Regulation of Tobacco Products; Request for Comments VIA Electronic Submission to http://www.regulations.gov September 29, 2009 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: Docket

More information

Hypertension: Developing Fixed- Dose Combination Drugs for Treatment Guidance for Industry

Hypertension: Developing Fixed- Dose Combination Drugs for Treatment Guidance for Industry Hypertension: Developing Fixed- Dose Combination Drugs for Treatment Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions

More information

Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA.

Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA. Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA (Laser Notice 51) Document issued on: May 27, 2001 U.S. Department of Health

More information

February 13, The Honorable Fred Upton 2183 Rayburn House Office Building Washington, DC Dear Chairman Upton:

February 13, The Honorable Fred Upton 2183 Rayburn House Office Building Washington, DC Dear Chairman Upton: NATIONAL OFFICE Advocacy and Access Department 1615 L Street, NW #320 Washington, DC 20036 February 13, 2015 The Honorable Fred Upton 2183 Rayburn House Office Building Washington, DC 20515 Dear Chairman

More information

Guidance for Industry

Guidance for Industry Reprinted from FDA s website by Guidance for Industry Bar Code Label Requirements Questions and Answers (Question 12 Update) DRAFT GUIDANCE This guidance document is for comment purposes only. Submit comments

More information

November 19, Dear Messrs. Holdren and Lander:

November 19, Dear Messrs. Holdren and Lander: John P. Holdren, Co-Chair Eric Lander, Co-Chair President s Council of Advisors on Science and Technology Executive Office of the President 1650 Pennsylvania Avenue, NW Washington, DC 20504 Dear Messrs.

More information

23 November Division of Dockets Management (HFA 305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852

23 November Division of Dockets Management (HFA 305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852 23 November 2016 Division of Dockets Management (HFA 305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Submitted via http://www.regulations.gov Re: Docket No. FDA-2016-N-1502,

More information

April 25, 2014 Reference No. HAMB FDA Transparency Initiative Regulations Development

April 25, 2014 Reference No. HAMB FDA Transparency Initiative Regulations Development Reference No. HAMB14001 Via Email Dr. Margaret Hamburg Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 margaret.hamburg@fda.hhs.gov SUBJECT: FDA Transparency

More information

December 4, 2017 VIA ELECTRONIC SUBMISSION

December 4, 2017 VIA ELECTRONIC SUBMISSION VIA ELECTRONIC SUBMISSION December 4, 2017 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Development of a List of pre-dietary Supplement

More information

Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA

Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA Document issued on: November 12, 2002 This document supersedes the

More information

Nonallergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry

Nonallergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry Nonallergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Citizen Petition to: Margaret A. Hamburg, M.D, Commissioner of Food and Drugs Docket No. For Review of Standard of Identity

More information

Preparing a US FDA Medical Device 510(K) Submission

Preparing a US FDA Medical Device 510(K) Submission Preparing a US FDA Medical Device 510(K) Submission If you want to introduce your medical device to the US market, you need to obtain clearance from the FDA. This clearance is obtained from the FDA via

More information

Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD Re: Docket No.

Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD Re: Docket No. December 2, 2016 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. Dear Sir or Madam: On behalf of the American Heart Association

More information

NEURONETICS. 510(k) SUMMARY NEUROSTAR TMS THERAPY SYSTEM'

NEURONETICS. 510(k) SUMMARY NEUROSTAR TMS THERAPY SYSTEM' NEURONETICS 510(k) SUMMARY NEUROSTAR TMS THERAPY SYSTEM' 510(k) Owner: Neuronetics, Inc. DEC 1 6 Z008 1 Great Valley Parkway, Suite 2 Malvern, PA 19355 Phone: 610-640-4202 Fax: 610-640-4206 Company Contact:

More information

Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing;

Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; 4160-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No. FDA-2013-N-0402] Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public

More information

Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 October 31, 2017 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket Nos. FDA 2012 N 1210 & FDA 2004 N 0258 Dear Sir or Madam: The (AHA)

More information

College of American Pathologists

College of American Pathologists College of American Pathologists Comments to the Food and Drug Administration on the draft guidance In Vitro Companion Diagnostics Devices October 12, 2011 College of American Pathologists 1350 I Street,

More information

Re: Docket No. FDA-2013-N-0521, Menthol in Cigarettes, Tobacco Products; Request for Comments

Re: Docket No. FDA-2013-N-0521, Menthol in Cigarettes, Tobacco Products; Request for Comments November 22, 2013 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2013-N-0521, Menthol in Cigarettes, Tobacco Products;

More information

Stakeholder Comments and Responses for

Stakeholder Comments and Responses for Stakeholder Comments and Responses for Comprehensive Research Plan: Treatment of ADHD in Adults Consolidated Report April 29 th, 2015 30 Bond Street, Toronto ON, M5B 1W8 www.odprn.ca info@odprn.ca 2 OVERALL

More information

February 15, AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

February 15, AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040 February 15, 2018 AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040 Re: K180137 Trade/Device Name: AtriCure cryoice cryo-ablation probe (CRYO3), AtriCure

More information

The STOP Measure. Safe and Transparent Opioid Prescribing to Promote Patient Safety and Reduced Risk of Opioid Misuse FEBRUARY 2018

The STOP Measure. Safe and Transparent Opioid Prescribing to Promote Patient Safety and Reduced Risk of Opioid Misuse FEBRUARY 2018 The STOP Measure Safe and Transparent Opioid Prescribing to Promote Patient Safety and Reduced Risk of Opioid Misuse FEBRUARY 2018 AHIP s Safe, Transparent Opioid Prescribing (STOP) Initiative Methodology

More information

February 2, Dear Dr. Shuren,

February 2, Dear Dr. Shuren, American Cancer Society Cancer Action Network 555 11 th Street, NW Suite 300 Washington, DC 20004 202.661.5700 www.acscan.org Jeffrey E. Shuren, M.D., J.D. Director, Center for Devices and Radiological

More information

May 7, Dear Mr. Landa:

May 7, Dear Mr. Landa: Ralph A. Simmons 202 429 6459 rsimmons@steptoe.com 1330 Connecticut Avenue, NW Washington, DC 20036-1795 202 429 3000 main www.steptoe.com May 7, 2013 Michael M. Landa Director, Center for Food Safety

More information

January 7, Dear Ms. Chung:

January 7, Dear Ms. Chung: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 January 7, 2015 Jeisys

More information

EPF s response to the European Commission s public consultation on the "Summary of Clinical Trial Results for Laypersons"

EPF s response to the European Commission s public consultation on the Summary of Clinical Trial Results for Laypersons EPF s response to the European Commission s public consultation on the "Summary of Clinical Trial Results for Laypersons" August 2016 This document received funding under an operating grant from the European

More information

CDRH: 510(k)S AND SCIENCE IN REGULATOR DECISION-MAKING. lannery, Scott Danzis and Christopher Pruitt. November 2010 SPECIAL REPRINT

CDRH: 510(k)S AND SCIENCE IN REGULATOR DECISION-MAKING. lannery, Scott Danzis and Christopher Pruitt. November 2010 SPECIAL REPRINT November 2010 SPECIAL REPRINT CDRH: 510(k)S AND SCIENCE IN REGULATOR ORY DECISION-MAKING By Ellen Flanner lannery, Scott Danzis and Christopher Pruitt Reproduced with the kind permission of Global Regulatory

More information

OBALON THERAPEUTICS, INC. (OBLN) The first and only FDA-approved swallowable, gas-filled intragastric balloon for weight loss

OBALON THERAPEUTICS, INC. (OBLN) The first and only FDA-approved swallowable, gas-filled intragastric balloon for weight loss OBALON THERAPEUTICS, INC. (OBLN) The first and only FDA-approved swallowable, gas-filled intragastric balloon for weight loss Forward looking statements Except for statements of historical fact, information

More information

MEASURING PATIENT AND OBSERVER-REPORTED OUTCOMES (PROS AND OBSROS) IN RARE DISEASE CLINICAL TRIALS - EMERGING GOOD PRACTICES TASK FORCE

MEASURING PATIENT AND OBSERVER-REPORTED OUTCOMES (PROS AND OBSROS) IN RARE DISEASE CLINICAL TRIALS - EMERGING GOOD PRACTICES TASK FORCE MEASURING PATIENT AND OBSERVER-REPORTED OUTCOMES (PROS AND OBSROS) IN RARE DISEASE CLINICAL TRIALS - EMERGING GOOD PRACTICES TASK FORCE Outline I. Introduction: Current environment of clinical research

More information

FDA Regulation of Diagnostic Tests Jeffrey N. Gibbs Hyman, Phelps & McNamara, P.C. Washington, DC

FDA Regulation of Diagnostic Tests Jeffrey N. Gibbs Hyman, Phelps & McNamara, P.C. Washington, DC AIPLA Annual Meeting Joint Biotechnology Committee/ Special Committee on FDA Law Program October 21, 2010 Marriott Wardman Park Hotel Washington, DC FDA Regulation of Diagnostic Tests Jeffrey N. Gibbs

More information

Lecture 2. Key Concepts in Clinical Research

Lecture 2. Key Concepts in Clinical Research Lecture 2 Key Concepts in Clinical Research Outline Key Statistical Concepts Bias and Variability Type I Error and Power Confounding and Interaction Statistical Difference vs Clinical Difference One-sided

More information

Guidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.

Guidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry DRAFT GUIDANCE This guidance

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Dosage Delivery Devices for OTC Liquid Drug Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this

More information

INTERPRETING REPORTS ON OBESITY PREVALENCE AND TRENDS. Key Considerations for Navigating the Evidence

INTERPRETING REPORTS ON OBESITY PREVALENCE AND TRENDS. Key Considerations for Navigating the Evidence INTERPRETING REPORTS ON OBESITY PREVALENCE AND TRENDS Key Considerations for Navigating the Evidence Accurate and meaningful estimates of prevalence and trends are fundamental to describing and understanding

More information

March 8, DxNow, Inc. Kevin Sly Senior Advisor to DxNow, Inc. 401 Professional Drive, Suite 130 Gaithersburg, Maryland

March 8, DxNow, Inc. Kevin Sly Senior Advisor to DxNow, Inc. 401 Professional Drive, Suite 130 Gaithersburg, Maryland March 8, 2018 Kevin Sly Senior Advisor to 401 Professional Drive, Suite 130 Gaithersburg, Maryland 20879-3429 Re: Trade/Device Name: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device

More information

May 6, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852

May 6, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852 May 6, 2016 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Submitted electronically via www.regulations.gov Re: Docket No. FDA-2014-N-1207

More information

June 9, PET FOOD INSTITUTE 2025 M Street, NW, Suite 800 Washington, DC M Street NW Suite 800 Washington, DC Page 1 of 6

June 9, PET FOOD INSTITUTE 2025 M Street, NW, Suite 800 Washington, DC M Street NW Suite 800 Washington, DC Page 1 of 6 PET FOOD INSTITUTE 2025 M Street, NW, Suite 800 Washington, DC 20036 (202) 367-1120 FAX (202) 367-2120 www.petfoodinstitute.org OFFICERS Chairman Bud Wright Texas Farm Products Vice Chairman Joe Sivewright

More information

HICPAC Recommendation Categorization Update Workgroup: Public Comment Summary and Finalization

HICPAC Recommendation Categorization Update Workgroup: Public Comment Summary and Finalization HICPAC Categorization Update Workgroup: Public Comment Summary and Finalization Deborah Yokoe and Daniel Diekema, Workgroup Co-Chairs HICPAC Presentation, November 2018 Disclaimer: The findings and conclusions

More information

MDCH IRB REVIEW APPLICATION Authority: Code of Federal Regulations Title 45 Part 46

MDCH IRB REVIEW APPLICATION Authority: Code of Federal Regulations Title 45 Part 46 The Michigan Department of Community Health Institutional Review Board for the Protection of Human Research Subjects Capitol View Building, 7 th Floor, 201 Townsend Street, Lansing, MI 48913 Phone: 517/241-1928

More information

The opinions expressed are the speaker s and not his company s.

The opinions expressed are the speaker s and not his company s. May 13, 2010 James Brooks, Ph.D. Vice President, Science & Technology Christine Burdick-Bell, J.D. Vice President, Legal & Regulatory Affairs Pharmavite LLC The opinions expressed are the speaker s and

More information

October 11, Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852

October 11, Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852 October 11, 2018 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: The Food and Drug Administration s Comprehensive, Multi-Year Nutrition

More information

Guidance on Returning Research Results to Subjects

Guidance on Returning Research Results to Subjects Guidance on Returning Research Results to Subjects 1. SCOPE 1.1. System Wide 2. DEFINITIONS & EXPLANATIONS OF TERMS 2.1. Anticipated finding: The planned outcome of the experiment or research activity.

More information

Comments in Response to the April 18 Workshop: Now Hear This: Competition, Innovation, and Consumer Protection Issues in Hearing Health Care

Comments in Response to the April 18 Workshop: Now Hear This: Competition, Innovation, and Consumer Protection Issues in Hearing Health Care Federal Trade Commission Office of the Secretary 600 Pennsylvania Avenue Washington, DC 20580 RE: Comments in Response to the April 18 Workshop: Now Hear This: Competition, Innovation, and Consumer Protection

More information

Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen

Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen Reprinted from FDA s website by EAS Consulting Group, LLC Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed

More information

The Role of Comparative Effectiveness in Health Reform

The Role of Comparative Effectiveness in Health Reform The Role of Comparative Effectiveness in Health Reform Vivian H. Coates, Vice President ECRI Institute National Congress 0n Health Reform 23 rd September, 2008 Washington, DC 1 2007 ECRI Institute What

More information

TFI WHO 20 Avenue Appia 1211 Geneva 27, Switzerland. Gentlemen:

TFI WHO 20 Avenue Appia 1211 Geneva 27, Switzerland. Gentlemen: Donald D. Foreman, Director Federal Government Affairs 1455 Pennsylvania Avenue, NW, Suite 925 Washington, DC 20004 Telephone: (202) 626-7200 Fax: (202) 626-7208 TFI WHO 20 Avenue Appia 1211 Geneva 27,

More information

July 6, Scott Gottlieb, MD Commissioner U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD 20993

July 6, Scott Gottlieb, MD Commissioner U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD 20993 Scott Gottlieb, MD Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 RE: Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education

More information

February 15, AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040

February 15, AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040 February 15, 2018 AtriCure, Inc. Melissa Smallwood Regulatory Affairs Specialist 7555 Innovation Way Mason, Ohio 45040 Re: K180138 Trade/Device Name: AtriCure cryoice cryo-ablation probe (CRYO2) Regulation

More information

F DA 'ac/0 --tii -oas SIEMENS. Sincerely, March 5, 2010

F DA 'ac/0 --tii -oas SIEMENS. Sincerely, March 5, 2010 SIEMENS March 5, 2010 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re : Docket No. FDA-2010-N-0054. Strengthening the Center for

More information

5101K] SUMMARY [as required by (c)]

5101K] SUMMARY [as required by (c)] 735-10, Ancheong-dong, Gwangsan-gu, Gwangju, Korea FAX:+82-62-954-1055 http://www. inarex. co. kr IN AR E)( TEL:+82-62-952-1052 INAREX CORPORATION 5101K] SUMMARY [as required by 807.92(c)] AUG 2 7 2008

More information

NOTICE OF INITIATION OF DISQUALIFICATION PROCEEDINGS AND OPPORTUNITY TO EXPLAIN

NOTICE OF INITIATION OF DISQUALIFICATION PROCEEDINGS AND OPPORTUNITY TO EXPLAIN DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike Rockville, MD 20852-1448 September 26, 2011 By Overnight Delivery Michael Dean Berger, M.D.

More information

ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits Guidance for Industry

ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits Guidance for Industry ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments

More information

Visionary Private Equity Group is Pleased to Announce its Investment in MEDITE Cancer Diagnostics

Visionary Private Equity Group is Pleased to Announce its Investment in MEDITE Cancer Diagnostics Dear VPEG Limited Partner, We hope this investor update finds you well. We're pleased to share with you an important update below on the following: Visionary Private Equity Group is Pleased to Announce

More information

A. Concentrated Omega-3 Dietary Supplements Provide Recognized Health Benefits

A. Concentrated Omega-3 Dietary Supplements Provide Recognized Health Benefits DEANNA TANNER OKUN Tel: (202) 407-8615 okun@adduci.com VIA ELECTRONIC FILING AND OVERNIGHT MAIL The Honorable Lisa R. Barton Secretary to the Commission United States International Trade Commission 500

More information

NDA NDA APPROVAL

NDA NDA APPROVAL DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022200 NDA APPROVAL Amylin Pharmaceuticals, Inc. Orville Kolterman, M.D. Sr. Vice President, Research & Development

More information

Exploring Outcomes and Value across the Spectrum of Alzheimer s Disease Pennsylvania Avenue NW, Washington, DC June 20, 2017

Exploring Outcomes and Value across the Spectrum of Alzheimer s Disease Pennsylvania Avenue NW, Washington, DC June 20, 2017 Exploring Outcomes and Value across the Spectrum of Alzheimer s Disease 1201 Pennsylvania Avenue NW, Washington, DC 20004 June 20, 2017 Meeting Summary Meeting Objectives Alzheimer s disease (AD) has a

More information

EHR Developer Code of Conduct Frequently Asked Questions

EHR Developer Code of Conduct Frequently Asked Questions EHR Developer Code of Conduct Frequently Asked Questions General What is the purpose of the EHR Developer Code of Conduct? EHR Association (the Association) members have a long tradition of working with

More information

Councilmember Nick Pacheco (Ret.)

Councilmember Nick Pacheco (Ret.) Councilmember Nick Pacheco (Ret.) Friday, November 17, 2017 Honorable Mike Feuer City Attorney 1300 I Street, Suite 125 Los Angeles, CA 90012 VIA EMAIL ONLY: MIKE.FEUR@LACITY.ORG RE: Legal Sufficiency

More information

Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases Draft

Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases Draft 1 2 3 21 May 2015 EMA/CHMP/50549/2015 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular

More information

Overhauling The 510(k) Process

Overhauling The 510(k) Process Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Overhauling The 510(k) Process Law360, New York (August

More information

April 1, Dear Members of the Pain Management Best Practices Inter-Agency Task Force,

April 1, Dear Members of the Pain Management Best Practices Inter-Agency Task Force, April 1, 2019 U.S. Department of Health and Human Services Office of the Assistant Secretary for Health 200 Independence Avenue, S.W., Room 736E, Attn: Alicia Richmond Scott, Task Force Designated Federal

More information

Patient Reimbursement Guide. Brainsway Deep Transcranial Magnetic Stimulation (TMS) Treatment. Obtain Coverage - the Right Way

Patient Reimbursement Guide. Brainsway Deep Transcranial Magnetic Stimulation (TMS) Treatment. Obtain Coverage - the Right Way Patient Reimbursement Guide Brainsway Deep Transcranial Magnetic Stimulation (TMS) Treatment Obtain Coverage - the Right Way Ever since Brainsway Deep TMS was approved by the FDA in 2013 for the treatment

More information

Patients Driving Progress

Patients Driving Progress Patients Driving Progress Ellen V Sigal, PhD WIN Symposium 2018 June 25, 2018 Paris, France Nothing to disclose The Evolution of Patient Advocacy The Agnew Clinic, Thomas Eakins (1899) Partial mastectomy

More information

The ICHS1 Regulatory Testing Paradigm of Carcinogenicity in rats - Status Report

The ICHS1 Regulatory Testing Paradigm of Carcinogenicity in rats - Status Report INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE The ICHS1 Regulatory Testing Paradigm of Carcinogenicity in rats - Status Report Introduction The ICH

More information

Testimony of. Eric J. Cassell, M.D., M.A.C.P. Member, National Bioethics Advisory Commission. and. Clinical Professor of Public Health

Testimony of. Eric J. Cassell, M.D., M.A.C.P. Member, National Bioethics Advisory Commission. and. Clinical Professor of Public Health Testimony of Eric J. Cassell, M.D., M.A.C.P Member, National Bioethics Advisory Commission and Clinical Professor of Public Health Cornell University Medical College Before the Subcommittee on Criminal

More information

Agenda. What we do. GMA - Overview 30,000. Public Private Partnerships in the Development of Food Safety Regulations. $415 billion

Agenda. What we do. GMA - Overview 30,000. Public Private Partnerships in the Development of Food Safety Regulations. $415 billion Agenda Public Private Partnerships in the Development of Food Safety Regulations Manojit Basu, PhD Senior Director, Product Safety and Regulatory Affairs, & Adjunct Professor, Johns Hopkins University

More information

Working Group Practices and Composition

Working Group Practices and Composition November 26, 2018 Tickborne Disease Working Group Office of the Assistant Secretary for Health U.S. Department of Health and Human Services 200 Independence Avenue, SW Washington, DC 20201 Dear Tickborne

More information

THE GENERAL ASSEMBLY OF PENNSYLVANIA SENATE BILL INTRODUCED BY DINNIMAN, FONTANA, SCHWANK, GREENLEAF, WARD AND FARNESE, APRIL 6, 2017

THE GENERAL ASSEMBLY OF PENNSYLVANIA SENATE BILL INTRODUCED BY DINNIMAN, FONTANA, SCHWANK, GREENLEAF, WARD AND FARNESE, APRIL 6, 2017 PRIOR PRINTER'S NO. 0 PRINTER'S NO. THE GENERAL ASSEMBLY OF PENNSYLVANIA SENATE BILL No. Session of 0 INTRODUCED BY DINNIMAN, FONTANA, SCHWANK, GREENLEAF, WARD AND FARNESE, APRIL, 0 SENATOR BAKER, HEALTH

More information

Sustaining and Diversifying Family Engagement in Title V MCH and CYSHCN Programs

Sustaining and Diversifying Family Engagement in Title V MCH and CYSHCN Programs A S S O C I A T I O N O F M A T E R N A L & C H I L D H E A L T H P R O G R A M S July 2016 Sustaining and Diversifying Family Engagement in Title V and Programs From late 2014 through early 2015, the

More information

Bacterin International Incorporated Mr. Howard L. Schrayer 600 Cruiser Lane Belgrade, Montana August 18, 2015

Bacterin International Incorporated Mr. Howard L. Schrayer 600 Cruiser Lane Belgrade, Montana August 18, 2015 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 Bacterin International

More information

February 27, Human Use. Dear Sir or Madam: new data and. responded to. United States. the United products.

February 27, Human Use. Dear Sir or Madam: new data and. responded to. United States. the United products. February 27, 2012 Division of Dockets Management Food and Drug Administration 5630 Fisherss Lane Room 1061, HFA-305 Rockville, Maryland 20852 Re: Docket No. 78N-0301: External Analgesic Drug Products for

More information

FDA 510(k) 101 The Basics

FDA 510(k) 101 The Basics FDA 510(k) 101 The Basics Floyd G. Larson President, PaxMed International San Diego, CA OMTEC June 17, 2010 Chicago Agenda History of 510(k) process FDA s risk based approach FDA guidance and standards

More information

FDA s Evidence-Based Review System

FDA s Evidence-Based Review System Food & Drug January 28, 2009 FDA Releases Final Guidance for Evidence-Based Review System for the Scientific Evaluation of Health Claims On January 16, 2009, the Food and Drug Administration (FDA) announced

More information