Direct-to-Consumer Promotion: FDA Update
|
|
|
- Ariel Randall
- 5 years ago
- Views:
Transcription
1 DTC National Direct-to-Consumer Promotion: FDA Update Marci Kiester, PharmD DDMAC, CDER April 17, 2009
2 Direct-to-Consumer Promotion: FDA Update Annual Update on DDMAC Organizational Structure and Submission Totals DTC Enforcements
3 The Division of Drug Marketing, Advertising, and Communications 01/26/09 Regulatory Counsel, Marissa Chaet Regulatory Counsel (Vacancy) Regulatory Counsel, (Vacancy) IT Specialist, Michael Wade Labeling, Iris Masucci Training & Support, Barbara Chong Director s Office Director, Thomas Abrams Deputy Director, Kristin Davis Associate Director, Mark Askine Special Assistant, Jean-Ah Kang Program Specialist, Becki Vogt Evidence Review & Division Support, Elaine Cunningham Project Manager, Wayne Amchin Project Manager, Paul Loebach TIA, Sharon Smith TIA, (Vacancy) Professional Review Group I Leader Jialynn Wang Neurology/ Psychiatry (Amy Toscano) Cardiovascular & Renal (Lisa Hubbard) Reproductive & Urology (Janice Maniwang) Medical Imaging & Hematology (Michelle Safarik) Professional Review Group II Leader Catherine Gray Oncology Drugs (JuWon Lee, Keith Olin, Karen Rulli ) Dermatology & Dental (Andrew Haffer) Professional Review Group III Acting Leader Sangeeta Vaswani Pulmonary & Allergy (Jessica Adams) Analgesics, Anesthetics, & Rheumatology (Mathilda Fienkeng) Metabolism & Endocrinology (Samuel Skariah) Gastroenterology, Special Pathogens & Transplant (Kathleen Klemm) Professional Review Group IV Leader Sheila Ryan Anti-Infectives & Ophthalmology (Beth Carr) Antivirals (Lynn Panholzer) Oncology Biologics (Carole Broadnax, Jeffrey Trunzo) Direct- To-Consumer Review Group I Leader Robert Dean Oncology Drugs, Oncology Biologics (Beverly Bowers, Stephanie Victor) Metabolic/Endocrine, Analgesics/Anesthetics Rheumatology (Kendra Jones, Michael Sauers) Derm/Dental and GI, Pulmonary/Allergy (Shefali Doshi, Robyn Tyler) Direct- To-Consumer Review Group II Leader Marci Kiester Cardio-renal (Zarna Patel) Psychiatry (Susannah Hubert) Neurology, Anti-Infectives, Ophthalmology, Special Pathogens, Transplant (Sharon Watson, Twyla Thompson) Antivirals (Aline Moukhtara) Research Team (Kathryn Aikin, Amie O Donoghue, Helen Sullivan) Reproductive, Urology, Medical Imaging, Hematology, (Cynthia Collins, Carrie Newcomer)
4 DTC Review Group Dockets Direct-to-Consumer Review Group I (Robert Dean) Oncology Drugs, Oncology Biologics (Beverly Bowers, Stephanie Victor) Metabolic/Endocrine, Analgesics/Anesthetics, Rheumatology (Kendra Jones, Michael Sauers) Derm/Dental and GI, Pulmonary/Allergy (Shefali Doshi, Robyn Tyler) Research Team (Kathryn Aikin, Amie O Donoghue, Helen Sullivan) Direct-to-Consumer Review Group II (Marci Kiester) Cardio-renal (Zarna Patel) Psychiatry (Susannah Hubert) Neurology, Anti-Infectives, Ophthalmology, Special Pathogens, Transplant (Sharon Watson, Twyla Thompson) Antivirals (Aline Moukhtara) Reproductive, Urology, Medical Imaging, Hematology (Cynthia Collins, Carrie Newcomer)
5 # of Final Promotional Pieces Submitted (2253s) ,000 70,000 60,000 50,000 40,000 30,000 20,000 10, , ,013 52,851 54,661 43,235 37,526 39,153 47, ,417 9,285 10,901 12, ,908 6, , Mixed Consumer Professional Total
6 # of Broadcast Ads Submitted Proposed Disseminated Total
7 DTC Enforcements Adderall XR Yaz Avodart Treximet Sponsored links
8
9 Adderall XR Warning Letter Video testimonial featuring Ty Pennington posted on youtube.com by Shire Development Inc (Shire) for Adderall XR Shire acknowledged its involvement in the development and dissemination of the video
10 Adderall XR Warning Letter Overstatement of Efficacy Ty claims Now once I got on medication it s just amazing the transformation I made. I It literally changed my life, and gave me the confidence to achieve my goals.... But the medicines like Adderall XR, it s truly a transformation.... It s not easy to communicate with people, including your own family. So you become kind of alienated. You feel like you re different, and you don t really fit in..... Proper treatment has truly changed my life and made an amazing difference.
11 Adderall XR Warning Letter Omission of Risk Information Video presents numerous efficacy claims but entirely omits risk information Failure to Submit Under Form 2253
12
13
14 Yaz Warning Letter Two TV ads Broadening of Indication Premenstrual Dysphoric Disorder (PMDD) Misleadingly suggest that Yaz is appropriate for treating women with PMS Nowhere do the ads use the full phrase premenstrual dysphoric disorder Omit material limitation that Yaz has not been evaluated for the treatment of premenstrual syndrome (PMS) Acne Fails to adequately convey that Yaz is only indicated for the treatment of moderate acne vulgaris
15 Yaz Warning Letter Overstatement of Efficacy PMDD TV ad Balloons misleadingly suggests that treatment with Yaz will allow women to say good-bye to their symptoms, when such an elimination has not been demonstrated by substantial evidence or substantial clinical experience Acne Overwhelming impression conveyed by the TV ads is that treatment with Yaz results in clear, acne-free skin for those women suffering from acne when this has not been demonstrated by substantial evidence or substantial clinical experience
16 Yaz Warning Letter Minimization of Risk Major statement minimized by distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information
17
18
19 Avodart Untitled Letter TV ad entitled Planetarium Misleading Comparative Claims So when my doctor said that my going and going could get worse because my prostate was growing I said How can we shrink it? He said Avodart. Avodart is different because over time it actually shrinks the prostate, so I go less often. Other medicines, they don t treat the cause, because they don t shrink the prostate.
20 Avodart Untitled Letter Overstatement of Efficacy Graphic images and verbal statements overstate the efficacy of Avodart therapy with respect to the results one can expect with Avodart Visual of the planet shrinking in size represents a reduction in prostate volume that is much greater than the reduction actually achieved with Avodart therapy in clinical trials
21 Treximet Untitled Letter Five online banners for Treximet Banners present efficacy claims prominently, utilizing techniques that are designed to emphasize this information, but relegate the risk information to a small, scrolling portion of the banner that is likely to be ignored by consumers.
22 Sponsored Link Untitled Letters Issued 14 untitled letters to 14 different companies regarding sponsored links on internet search engines Letters covered 48 drugs 19 of the products carry Boxed Warnings Violations included: Broadening or inadequately disclosing the actual FDA-approved use of the drugs Overstating the drugs benefits Not providing any risk information Failing to use the drug s established name
23 Sponsored Link Untitled Letters In situations where we notice common problems across a therapeutic area s promotion or across a certain promotional channel or vehicle, we may issue multiple letters simultaneously to maintain a level playing field We are concerned from a public health perspective whenever promotion undermines the safe use of a drug by minimizing the risks associated with the product or by failing to appropriately communicate its approved uses.
24 Tips for How to Submit to DDMAC Consult DDMAC s website prior to submitting materials ( For time sensitive materials, please confirm receipt of the submission to DDMAC with a phone call to the project manager or appropriate reviewer ( )
25 Contact Information CDR Marci Kiester, PharmD Group Leader Division of Drug Marketing, Advertising, and Communications
DTC National Conference
DTC National Conference Direct-to-Consumer Promotion Bob Dean DDMAC, CDER April 9, 2010 Direct-to-Consumer Promotion: FDA Update Annual Update on DDMAC Organizational Structure Submission Totals Review
Regulation of the Promotion of Prescription Drugs
Regulation of the Promotion of Prescription Drugs Thomas Abrams, R.Ph., M.B.A. Division of Drug Marketing, Advertising, and Communications Food and Drug Administration August 23, 2006 Goal and Objectives
Levitra According to its FDA-approved product labeling (PI), Levitra is indicated for the treatment of erectile dysfunction.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Fadwa Almanakly Associate Director, Global Regulatory Affairs Bayer
WARNING LETTER. (F)or the prevention of pregnancy in women who elect to use an oral
~t-t\ Si-Vf('i.s '&, 5~ (: ~EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Reinhard Franzen President & Chief Executive
According to the Indications and Usage section of the approved product labeling (PI): 1
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE George Marchesini Associate Director, Global Regulatory Affairs
WARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE David E.I. Pyott Chairman of the Board and Chief Executive Officer
Michelle Sharp, PharmD Director, US Regulatory Affairs Lilly Corporate Center Indianapolis, IN 46285
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Michelle Sharp, PharmD Director, US Regulatory Affairs Lilly Corporate
Brian Deutsch Associate, Regulatory Affairs Warner Chilcott (US), LLC 100 Enterprise Drive Rockaway, NJ 07866
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Brian Deutsch Associate, Regulatory Affairs 100 Enterprise Drive
WARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE James Manuso, Ph.D. Chairman, President, and Chief Executive Officer
According to the INDICATIONS AND USAGE section of its FDA-approved product labeling (PI):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Karen L. Walles, M.S. Assistant Director, Regulatory Affairs 3
John C. Kim, RPh, JD Senior Director, Regulatory Affairs Ferring Pharmaceuticals Inc. 4 Gatehall Drive 3 rd Floor Parsippany, NJ 07054
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 John C. Kim, RPh, JD Senior Director, Regulatory Affairs Ferring Pharmaceuticals Inc. 4
WARNING LETTER. ( (last accessed July 10, 2009).
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Miles D. White Chairman of the Board & Chief Executive Officer
TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Kirsten Dale Manager, Regulatory Affairs Promotion/Advertising
TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Sue Duvall, RN, MPA Associate Director, Drug Regulatory Affairs Pharmaceuticals
Below is the indication and summary of the most serious and most common risks associated with the use of Naftin Cream, 2%. 2
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Misty M. D Ottavio, Senior Manager Regulatory Affairs 4215 Tudor
WARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Carole S. Ben-Maimon, M.D. President and Chief Operating Officer One
WARNING LETTER TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Samuel D. Waksal, Ph.D. Chairman and Chief Executive Officer 119
According to the Indications and Usage section of the FDA-approved product labeling (PI) 1 :
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Rexner Vargas, Senior Manager, Regulatory Affairs Amylin Pharmaceuticals,
Gary Wieczorek, Associate Director, Regulatory Affairs Eisai Medical Research Inc. 300 Tice Blvd Woodcliff Lake, NJ 07677
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Gary Wieczorek, Associate Director, Regulatory Affairs 300 Tice
WARNING LETTER. Robert Essner Chairman and Chief Executive Officer Wyeth Pharmaceuticals Inc. P.O. Box 8299 Philadelphia, PA
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Robert Essner Chairman and Chief Executive Officer P.O. Box 8299 Philadelphia,
Consultant Services to Kansas Family Physicians
Consultant Services to Kansas Family Physicians The purpose of this study is to track the use of consultants. An e-mail survey was sent to 114 Kansas family physicians The survey was launched on 11/25/2009
WARNING LETTER. According to the INDICATIONS AND USAGE section of the FDA-approved product labeling (PI)' for Tykerb:
EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Chief Executive Officer GlaxoSmithKline P.O. Box 13398 Five Moore
RE: NDA # Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets MACMIS # 18360
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Joyce Q. Acbay Director, Regulatory Affairs 333 Lakeside Drive
E-ALERT Food & Drug 2011 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY OPDP I. ENFORCEMENT ACTIVITY
E-ALERT Food & Drug February 7, 2012 2011 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY This client alert reviews the warning and untitled letters issued in 2011 by the Office of Prescription
WARNING LETTER. ( (ORA05050) for OrapredCI (prednisolone sodium phosphate
+t-tlserviçès-,& v,ù',' : -::~.,'" ( -ldepartment OF HEALTH & HUMAN SERVICES 'P"~~\- Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE October 11, 2006 Jean-Jacques
DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Stacy Holdsworth, PharmD Manager U.S. Regulatory Affairs Lilly Technology
E-ALERT Food & Drug SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES FEBRUARY April 5, 2010
E-ALERT Food & Drug April 5, 2010 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES FEBRUARY 2010 This e-alert is part of a monthly series of e-alerts summarizing publicly-available FDA enforcement
Food & Drug SUMMARY OF DDMAC AND APLB ENFORCEMENT CORRESPONDENCE JULY 2009
Food & Drug August 31, 2009 SUMMARY OF DDMAC AND APLB ENFORCEMENT CORRESPONDENCE JULY 2009 In July 2009, FDA s Division of Drug Marketing, Advertising, and Communications (DDMAC) posted two warning letters
WARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Cary Rayment President and Chief Executive Officer Alcon, Inc. C/O
OPDP Update on Oversight of Prescription Drug Promotion
OPDP Update on Oversight of Prescription Drug Promotion Thomas Abrams Director Office of Prescription Drug Promotion Food and Drug Administration September 26, 2017 Goal and Objectives Goal To protect
WARNING LETTER TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE John Lechleiter, Ph.D. President & Chief Executive Officer Eli Lilly
WARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Henry A. McKinnell, Jr., Ph.D. Chairman of the Board and Chief Executive
Duragesic has the potential for abuse. The Drug Abuse and Dependence section of the PI states, in pertinent part:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Ajit Shetty, M.D. CEO Janssen Pharmaceutics, Inc. 1125 Trenton-Harbourton
Adding Quantitative Benefit Information to DTC Promotion. Helen W. Sullivan, Ph.D., M.P.H.
DTC National Conference Washington, DC April 10-12, 2012 Adding Quantitative Benefit Information to DTC Promotion Helen W. Sullivan, Ph.D., M.P.H. Office of Prescription Drug Promotion Food and Drug Administration
WARNING LETTER. The Indications and Usage section of the approved product labeling (PI) for Prograf states:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Hideo Fukumoto CEO Three Parkway North Deerfield, IL 60015-2548 RE:
WARNING LETTER. According to the Indications and Usage section of the FDA approved product labeling (PI):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE David E.I. Pyott President and Chief Executive Officer PO Box 19534
Below are the indication (in pertinent part) and summary of the most serious and most common risks associated with the use of Tindamax.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Eric White Senior Vice President Regulatory Affairs & Quality Assurance 10999 Interstate
Randy Russell Assistant Director, Regulatory Affairs Alcon Research, Ltd South Freeway, R3-54 Fort Worth, TX
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Randy Russell Assistant Director, Regulatory Affairs 6201 South Freeway, R3-54 Fort Worth,
2017 ST3 Competition Ratios Medical Specialties
2017 ST3 Competition Ratios Medical Specialties Applications Received Posts Available Competition Ratio Acute Internal Medicine 245 125 1.96 Allergy 8 3 2.67 Audiovestibular Medicine 9 1 9 Cardiology 361
WARNING LETTER. RE: NDA# COPAXONE (glatiramer acetate injection) solution for subcutaneous injection MA #762. Dear Mr.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Larry Downey Executive Vice President, US Branded Pharmaceuticals Teva Pharmaceuticals USA
DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Nancy Konnerth Associate Director, Advertising and Labeling Drug Regulatory
According to its FDA-approved product labeling (PI), Isovue is indicated for the following (in pertinent part):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Melanie Benson Director, US Regulatory Affairs 107 College Road
REVIEW MANAGEMENT. Clinical Review of Drugs to Reduce the Risk of Cancer CONTENTS
REVIEW MANAGEMENT Clinical Review of Drugs to Reduce the Risk of Cancer CONTENTS PURPOSE BACKGROUND REFERENCES DEFINITIONS AND ACRONYMS POLICY PROCEDURES EFFECTIVE DATE PURPOSE This MAPP describes: The
,~~~ WARNING LETTER. Frank Baldino, Jr., Ph.D. Chairman and Chief Executive Officer Cephalon, Inc. 41 Moores Road P.O. Box 4011 Frazer, PA USA
'>~,,~..t'~\i'icl"$_.(,~ ( -i1f!..department OF HEALTIl & HUMAN SERVICES,~~~ Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Frank Baldino, Jr., Ph.D. Chairman
ANESTHESIOLOGY Comments:
ANESTHESIOLOGY *Four-week clinical anesthesiology elective Four weeks in subspecialty areas of anesthesiology (cardiovascular, obstetrics, etc.) or research Cardiology Cardiology graphics ICU Infectious
Inspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Burzynski Research Institute
1 of 9 6/25/17 1:22 AM
News & Perspective Drugs & Diseases CME & Education Academy Consult Video Email This Your Name: Specialty: Emergency Medicine Allergy & Immunology Anesthesiology Business of Medicine Cardiology Critical
The PI includes important warnings and precautions. It states (in pertinent part):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE James L. Gaskill, PharmD Director Promotional Regulatory Affairs AstraZeneca
E-ALERT Food & Drug 2013 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY OFFICE OF PRESCRIPTION DRUG PROMOTION (OPDP)
E-ALERT Food & Drug April 25, 2014 2013 END-OF-YEAR SUMMARY OF FDA PROMOTIONAL ENFORCEMENT ACTIVITY This alert reviews the warning and untitled letters issued in 2013 by the Office of Prescription Drug
1 st Annual Treatment-Related Adverse Events Symposium: FOCUS ON MANAGEMENT. Friday, October 27, Zuckerman Research Center, New York City
1 st Annual Treatment-Related Adverse Events Symposium: FOCUS ON MANAGEMENT Friday, October 27, 2017 Zuckerman Research Center, New York City 1 st Annual Treatment-Related Adverse Events Symposium: FOCUS
WARNING LETTER DEPARTMENT OF HEALTH & HUMAN SERVICES TRANSMITTED BY FACSIMILE
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Ajit Shetty, M.D. CEO Janssen Pharmaceutica, Inc. 1125 Trenton-Harbourton
AVMED SPECIALIST/SPECIALTIES REQUIRING MEDICARE REFERRAL
Addiction Psychiatry Adolescent Medicine (Family Practice) Adolescent Medicine (Pediatric) Adult Congenital Heart Disease Advanced Heart Failure and Transplant Cardiology Aerospace Medicine Allergy & Immunology
FDA s Office of Prescription Drug Promotion (OPDP) Enforcement: A Summary of 2013 Warning and Untitled Letters
February 27, 2014 FDA s Office of Prescription Drug Promotion (OPDP) Enforcement: A Summary of 2013 Warning and Untitled Letters Jennifer A. Romanski, J.D. Director, Regulatory and Compliance Services
Inspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Stanislaw R Burzynski, MD 12/3/13
NARB PANEL #222. Appeal of the NAD Final Decision Regarding Advertising for Phillips Oral Healthcare LLC s Philips Sonicare FlexCare Platinum
NARB PANEL #222 Appeal of the NAD Final Decision Regarding Advertising for Phillips Oral Healthcare LLC s Philips Sonicare FlexCare Platinum Panel Members Scott Hamula (Chair) Associate Professor and Chair
Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs
This document is scheduled to be published in the Federal Register on 12/13/2016 and available online at https://federalregister.gov/d/2016-29770, and on FDsys.gov [BILLING CODE: 6750-01S] FEDERAL TRADE
WARNING LETTER. The Indications and Usage section of the FDA-approved product labeling (PI) states (emphasis original):
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED VIA FACSIMILE Cary R. Rayment President and Chief Executive Officer 6201 South Freeway
WARNING LETTER. MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP)
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration TRANSMITTED BY FACSIMILE Steven Hanley President Imaging Division Mallinckrodt Inc. 675 McDonnell Boulevard P.O.
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,
E-ALERT Food & Drug SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MARCH April 28, 2010
E-ALERT Food & Drug April 28, 2010 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MARCH 2010 This e-alert is part of a monthly series of e-alerts summarizing publicly-available FDA enforcement
In May 2013, FDA s Office of Prescription Drug Promotion (OPDP) posted the following enforcement letters on FDA s website 1 :
E-ALERT Food & Drug June 27, 2013 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MAY 2013 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement
Consistent with Labeling Final Guidance: Implications for Devices
Consistent with Labeling Final Guidance: Implications for Devices Vernessa Pollard, Partner, McDermott Will & Emery Cassie Scherer, Principal Legal Counsel, Medtronic Jeffrey Shapiro, Director, Hyman,
Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers Draft Guidance for Industry
Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers Draft Guidance for Industry Elizabeth Pepinsky Health Science Policy Analyst Office of Prescription
Letter to the AMGA Board of Directors...1 Introduction...3
Table of Contents Letter to the AMGA Board of Directors...1 Introduction...3 Section I: Executive Summary Survey at a Glance...6 Participant Profile...10 Survey Methodology...18 How to Use This Report...21
GUIDELINES FOR MAKING PRODUCT CLAIMS
GUIDELINES FOR MAKING PRODUCT CLAIMS This practical guide to making claims provides valuable information for Independent Business Owners (IBOS) to use in their everyday operations. It describes various
Is POM Wonderful Really Wonderful? How the FTC, the FDA and Private Litigation Address Deceptive Food Advertising
Is POM Wonderful Really Wonderful? How the FTC, the FDA and Private Litigation Address Deceptive Food Advertising Dee Pridgen October 9, 2014 14 th Consumer Issues Conference Pom Wonderful achieve immortality?
L A W O F F I C E S HYMAN, PHELPS & MCNAMARA, P.C.
A. WES SIEGNER, JR. L A W O F F I C E S 7 0 0 T H I R T E E N T H S T R E E T, N. W. S U I T E 1 2 0 0 W A S H I N G T O N, D. C. 2 0 0 0 5-5 9 2 9 ( 2 0 2 ) 7 3 7-5 6 0 0 F A C S I M I L E ( 2 0 2 ) 7
August but not posted to the website by August 31, 2010 will be summarized in our alerts for the months in which those letters are posted.
E-ALERT Food & Drug November 4, 2010 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES AUGUST 2010 This e-alert is part of a monthly series of e-alerts summarizing publicly-available FDA
Submission of Webicina.com for the Social Innovation Tournament
Submission of Webicina.com for the Social Innovation Tournament Webicina LLC Bertalan Mesko, MD Twitter.com/Berci info@webicina.com Skype: ncurse How does Webicina serve the public? Webicina.com curates
M4 Coursework Information
M4 Coursework Information This guide is intended to assist students in selecting and scheduling courses based upon their specialty of interest. Contents ANESTHESIOLOGY... 1 DERMATOLOGY... 2 EMERGENCY MEDICINE...
Letter to the AMGA Board of Directors...1 Introduction...3
Table of Contents Letter to the AMGA Board of Directors...1 Introduction...3 Section I: Executive Summary Survey at a Glance...6 Participant Profile...10 Survey Methodology...18 How to Use This Report...21
Aligning a Product s Marketing, Regulatory and IP Plans
Aligning a Product s Marketing, Regulatory and IP Plans CLIENT ALERT September 8, 2017 Raymond A. Miller millerra@pepperlaw.com Barry H. Boise boiseb@pepperlaw.com Jessica A. Rickabaugh rickabaughj@pepperlaw.com
Leeds Children s Hospital Aiming high, delivering the best
Leeds Children s Hospital Aiming high, delivering the best we were in expert hands Leeds Children s Hospital is one of the leading hospitals for children and young people in the United Kingdom, with a
Letter to the AMGA Board of Directors... 1 Introduction... 3
Table of Contents Letter to the AMGA Board of Directors... 1 Introduction... 3 Section I: Executive Summary Survey at a Glance... 6 Participant Profile... 10 Survey Methodology... 19 How to Use This Report...
HOSPITAL MEDICINE BECOMING A PHYSICIAN
HOSPITAL MEDICINE BECOMING A PHYSICIAN DR MIKE MASDING Consultant Physician & Diabetologist Poole Hospital NHS Foundation Trust 24 September 2010 Hospital Medicine Becoming a Physician What is a Physician?
Letter to the AMGA Board of Directors... 1 Introduction... 3
Table of Contents Letter to the AMGA Board of Directors... 1 Introduction... 3 Section I: Executive Summary Survey at a Glance... 6 Participant Profile... 10 Survey Methodology... 19 How to Use This Report...
E-ALERT Food & Drug April 30, 2012
E-ALERT Food & Drug April 30, 2012 SUMMARY OF FDA ADVERTISING AND PROMOTION ENFORCEMENT ACTIVITIES MARCH 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement
Telemedicine Centre. All India Institute of Medical College,Bhopal. Statistics of Video Conferencing [October 2013-December 2017]
![Telemedicine Centre. All India Institute of Medical College,Bhopal. Statistics of Video Conferencing [October 2013-December 2017]](/thumbs/83/88715243.jpg "Telemedicine Centre. All India Institute of Medical College,Bhopal. Statistics of Video Conferencing [October 2013-December 2017]")
Telemedicine Centre All India Institute of Medical College,Bhopal Statistics of Video Conferencing [October 0-December 0] S.No. Activities No. of Sessions Video Conferencing in Hours Tele-education sessions
The European Board of Urology
Page 1 of 15 The European Board of Urology Sub-specialty certification application: Prostate cancer, A - General information A1 - APPLICATION IDENTIFICATION 1a. Application code blank 1b. EBU internal
September 20, Thomas Scully Administrator Centers for Medicare and Medicaid Services 200 Independence Avenue SW Washington, DC 20201
September 20, 2001 Thomas Scully Administrator Centers for Medicare and Medicaid Services 200 Independence Avenue SW Washington, DC 20201 Dear Mr. Scully: The medical organizations listed below would like
I-1 TIME SERIES - MOST RECENT FIVE YEARS Field of post-m.d. training and source of funding
Family Medicine Emergency Medicine (CFPC) Care of the Elderly (CFPC) Enhanced Skills: Fam. Med. Training FAMILY MEDICINE SUBTOTAL Anesthesiology Critical Care (Anes.) Pain Medicine (Anes.) Public Health
2015 Detailed Postgraduate Training Report: Grampian
2015 Detailed Training Report: Grampian out of hours Aberdeen Maternity Hospital - N161H Community Sexual and Reproductive Health ST 1 Aberdeen Maternity Hospital - N161H Obstetrics and Gynaecology F2
SPECIALTY CPT CODES DESCRIPTION
Primary Care Physicians: Internal Medicine, Family Practice, Pediatrics 71010, 71020, 71021, 71022, 71030, 71100, 71101, 71110, 72010, 72020, 72040, 72050, 72052, 72070, 72080, 72100, 72110, 72114, 72170,
Document Number: HR Title: Tobacco-Free Campus Approved: 07/03/2014 Effective Date: 08/01/2014 Revised Dated:
Document Number: HR 6.024 Title: Tobacco-Free Campus Approved: 07/03/2014 Effective Date: 08/01/2014 Revised Dated: Tobacco-Free Campus Policy Policy Statement Pursuant to Act 211 (also known as Senate
RESULTS AT A GLANCE. FDA Oversight of Tobacco Manufacturing Establishments. HHS OIG Data Brief August 2017 OEI
HHS OIG Data Brief August 2017 OEI-01-15-00300 FDA Oversight of Tobacco Manufacturing Establishments RESULTS AT A GLANCE The Tobacco Control Act authorized FDA to regulate domestic tobacco manufacturers
Electives Diversification Policy
Electives Policy Rationale The Association of Faculties of Medicine of Canada Undergraduate Deans acknowledge the role that electives play as part of the curriculum of every medical program in Canada.
Building Successful Telemedicine Programs/Applications Overview
Building Successful Telemedicine Programs/Applications Overview Ronald S. Weinstein, M.D. Director, Arizona Telemedicine Program Professor, Dept. of Pathology College of Medicine University of Arizona
Clinical Research Resources
Clinical Research Resources SOM New Faculty Orientation August 2017 Pamela G. Terry, MBA, JM Associate Executive Director, University Resources ACTSI Atlanta Clinical & Translational Science Institute
Update on the Clinical Outcome Assessment Qualification Program and COA Compendium
Update on the Clinical Outcome Assessment Qualification Program and COA Compendium Seventh Annual PRO Consortium Workshop April 27-28, 2016 Michelle Campbell, PhD Clinical Outcomes Assessment Staff (COA
Limitations of the HRG Tariff: The trim point
Limitations of the HRG Tariff: The trim point Dr Rod Jones (ACMA) Statistical Advisor Healthcare Analysis & Forecasting hcaf_rod@yahoo.co.uk For further articles in this series please go to: www.hcaf.biz
Health Center Directory
U N I V E R S I T Y H O S P I TA L S M E N T O R H E A LT H C E N T E R Health Center Directory Provider listings are current as of October 2015. Copies of this directory are available as a printable file
Information contained in this listing is collected and maintained by the American Board of Internal Medicine.
1936-1940 1936 1937 1938 1939 1940 Decade Internal Medicine 27 209 90 227 255 808 1941-1950 1941 1942 1943 1944 1945 1946 1947 1948 1949 1950 Decade Internal Medicine 242 204 342 271 314 473 654 486 335
Journal Subsciption Rate (Print) + Online Free Year: 2019 Postage, Shipping and handling is FREE (3 times in a year) Website:
1 Annual Research & Review in Biology 473 437 374 20556 2 Asian Food Science Journal 177 163 140 4556 3 Asian Journal of Advances in Agricultural Research 202 186 159 5889 4 Asian Journal of Agricultural
Oklahoma State Board of Medical Licensure and Supervision Certification Boards & SubSpecialties
100 ABPS - Administrative Medicine 101 ABPS - Anesthesiology 106 ABPS - Board of Certification in Family Medicine Obstetrics (BCFMO) 120 ABPS - BOARD OF CERTIFICATION IN RADIOLOGY 102 ABPS - Dermatology
Hawaii Physician Workforce Assessment 2015
Act 18, SSLH 2009 (Section 5) Act 186, SSLH 2012 Hawaii Physician Workforce Assessment 2015 Kelley Withy, MD, PhD withy@hawaii.edu www.ahec.hawaii.edu Physician Workforce Specifics >9,100 licensed 3,596
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
Nestle Infant Nutrition 10/31/14
U.S. Food and Drug Administration Protecting and Promoting Your Health Nestle Infant Nutrition 10/31/14 OCT 31, 2014 Department of Health and Human Services Public Health Service Food and Drug Administration
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
Appendix F The Child Dissociative Experience Scale and Post-Traumatic Stress Inventory (CDES/PTSI)
Appendix F The Child Dissociative Experience Scale and Post-Traumatic Stress Inventory (CDES/PTSI) 6241-009da-1pass-BM7-r03.indd 262 10/1/2012 11:25:40 PM CHILDREN S EXPERIENCES [WF], page 1 Bradley C.
DEPARTMENT OF MEDICINE RESIDENCY PROGRAM - ELECTIVES CATALOGUE
DEPARTMENT OF MEDICINE RESIDENCY PROGRAM - ELECTIVES CATALOGUE I. Introduction This document outlines the various elective and research options available to UCI Internal Medicine House Officers. Each house