Political Economy of the Medical Products Industry
|
|
- Lynn Ward
- 5 years ago
- Views:
Transcription
1 Political Economy of the Medical Products Industry Tom Hazlet Survey of Biomedical Regulatory Affairs Spring 2008 Menu Definitions medical products political economy Commodities drugs devices biologics veterinary medicine dietary supplements Actors manufacturers regulators consumers self-pay insurers governmental insurers Issues cost of... drugs industry performance speculations re devices 1 Sneaky approach to making it all fit together. 2 defn: medical products defn: political economy The Food and Drug Administration (FDA) announced a broad initiative to help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products while maintaining FDA's traditional high standards of consumer protection. This is an FDA-wide initiative, involving all four of FDA's medical product review centers (drugs, biologics, devices, and veterinary medicine). FDA intends to achieve this goal through new actions in three major areas: Reducing the delays and avoidable product development costs by avoiding multiple cycles of FDA review when possible, through early communication and other steps to improve the quality of new product applications Improving the quality and efficiency of the review process, by adopting a quality systems approach to medical product reviews Facilitating new product development, by providing clearer up-to-date guidance for particular diseases and for emerging technologies Political Economists are concerned with the allocation of scarce resources in a world of infinite wants and needs. In order to allocate these resources, politics are used within a state to provide for the people. Political economy is the study of the relationships between individuals and society, and more specifically, the relationships between citizens and states. Political economy is a study of philosophy and ideology that studies the evolution of political and economic ideas. Political economy is a mixture of politics, economics, sociology, philosophy, and history, which all bring together evidence to the study of how humans exist within societies. Political economists study political ideology, economic structure, human interaction, human nature, and theories in philosophical thought. It is a study that studies not only the mechanics of a particular structure, but also the reasoning behind why a structure is regarded to be the best by various people with different beliefs accessed
2 more Medical Products Political Economy A Framework in Econ-Speak (after Comanor) Free Market Model Economics is a practical science. Since its inception as an independent discipline, it has probed the major policy issues of the day. The topics that aroused the interests of its practitioners have generally been those that presented government officials with critical choices. The modern literature on the economics of the pharmaceutical industry is no exception. a free market is a market where trades are morally voluntary and therefore free from the interference of force and fraud 1 market failure remedies Competition & Monopoly R&D determinants of expenditures scale economies costs & returns from R&D 1 Comanor WS. The Political Economy of the Pharmaceutical Industry. J Econ Lit 1986;24(30): framework - 2 framework - 3 Advertising & Promotion volume of industry outlays impact on competition effect on information Impact of regulation patent policy regulatory scrutiny [product liability] drug lag effects on price and market share costs & benefits of regulation Social returns form R&D USC CFR Range gross regulatory divisions 7 8
3 Commodities: drugs (CDER) 21USC: 321, [Act 201, ] 21CFR: Range over-the-counter (OTC) prescription (legend Caution: Federal law ) after 38 Act; 51 Durham- Humphrey Amendment controlled substance commodities: medical devices (CDRH) 21USC: 321, [Act 201, ] 21CFR: 800 s, 900 Device Class and Regulatory Controls Class I General Controls With Exemptions Without Exemptions Class II General Controls and Special Controls With Exemptions Without Exemptions Class III General Controls and Premarket Approval 9 10 commodities: biologicals (CBER) commodities: veterinary medicine USC: FD&C + Public Health Service Act USC Chapter 6A gg CFR: 600 Blood, blood products, IVDs associated with blood, vaccines, allergenic extracts, body parts(?); areas of expertise 21USC321, [Act 201, ] 21CFR: 500 s in the food chain Fido note: licensed at the Secretary s pleasure; cf. approved 11 12
4 commodities: dietary supplements Actors (aka stakeholders ) 21USC Chapter IV ( d) 21CFR 100 s, 573, 582 specified in the Dietary Supplement & Health Education Act of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent or extract. A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement manufacturers brick & mortar virtual companies campaign manufacturers regulators FDA international equivalents virtual regulators standards organizations USP/NF ICH ISO UL; equivalent organizations in Canada, EU insurers; special interest groups before October 15, actors - 2 consumers self-pay often pays the most insurers networks to assure access; contractual relationships with providers governmental insurers federal Medicare; federal employees; (Medicaid) state varies widely; Medicaid; BHP, UMP (WA) Issues cost of medical products a free market? patent structure monopolies drugs generics biologics immortal medical devices some double-speak if it s substantially equivalent price discrimination vs. cost shifting product life cycle and barriers to entry price controls 15 16
5 Issues 2 Role of governmental investment in innovation issues -- 3 Industry performance 19 20
6 speculation regarding Medical Device Industry... it depends many products evolve incrementally rather than by blockbuster reimbursement much more diffuse product cycle much shorter 5 years much less information about industry; much less scientific literature about products questions Points of emphasis Interplay between manufacturers, consumers, regulatory bodies Markets, market failure, remedies Cost of medical products; market segmentation 23 24
FDA Laws & Pharmacy Practice
Objectives FDA Laws & Pharmacy Practice Tom Hazlet Pharmacy 543 October 6, 2004 Be able to discuss the evolution of food and drug law in the United States Be able to discuss the ways in which pharmacists
More informationFDA Laws & Pharmacy Practice
Objectives FDA Laws & Pharmacy Practice Tom Hazlet Pharmacy 543 Autumn 2006 Be able to discuss the evolution of food and drug law in the United States Be able to discuss the ways in which pharmacists and
More informationGetting Your Ingredient to Market: Understanding Your Regulatory Options Venable LLP
Getting Your Ingredient to Market: Understanding Your Regulatory Options 2013 Venable LLP 1 Overview of the Governing Laws 1. The Federal Food, Drug, and Cosmetic Act ("FD&C Act"): Requires foods, cosmetics,
More informationGuidance 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 informationNaloxone Expanded Access: OTC status Considerations for a Nonprescription Drug Development Program
Naloxone Expanded Access: OTC status Considerations for a Nonprescription Drug Development Program Andrea Leonard-Segal, M.D., M.S. Director, Division of Nonprescription Clinical Evaluation 1 Contents
More informationNDI: LOOKING BACK & AHEAD
NDI: LOOKING BACK & AHEAD Chi Hee Kim D i r e c t o r, W o r l d w i d e R e g u l a t o r y, G o v e r n m e n t a n d I n d u s t r y A f f a i r s H e r b a l i f e I n t e r n a t i o n a l o f A m
More informationUsing and Referencing ISO and IEC Standards for Technical Regulation
Using and Referencing ISO and IEC Standards for Technical Regulation Third ANSI Conference on U.S. Leadership in ISO and IEC May 23-24, 24, 2007 Chicago, IL David P. Kelly, M.I.M. Office of International
More informationTaylor C. Wallace, PhD, CFS, FACN, March 22, 2018
Food Ingredients Taylor C. Wallace, PhD, CFS, FACN, March 22, 2018 Disclosures Think Healthy Group, Inc. George Mason University, Department of Nutrition and Food Studies Journal of the American College
More informationWHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS
WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS SEPTEMBER 23, 2009 COUNCIL OF THE CONVENTION SECTION ON THE QUALITY OF FOOD INGREDIENTS AND DIETARY SUPPLEMENTS INTRODUCTION The 1994 Dietary Supplement
More informationRE: Permits under the Arizona Pharmacy Act should not be required for dietary supplements
Board Members Arizona State Board of Pharmacy 1616 W. Adams St., Suite 120 Phoenix, AZ 85007 c/o Kam Gandhi, PharmD Executive Director Arizona State Board of Pharmacy Via email: kgandhi@azpharmacy.gov
More informationFDA Regulation of Claims on Dietary Supplement and Food Products
FDA Regulation of Claims on Dietary Supplement and Food Products Patricia Kaeding August 2004 Topics FDA Overview What are claims Why claims matter Categories of claims Regulatory requirements for types
More informationFundamentals of Pharmacology for Veterinary Technicians Chapter 1
1906 1914 1933 1937 1938 1941 1951 1965 1968 1970 1970 1972 1972 1983 1984 1988 1994 1994 1996 1997 2001 2003 2008 The original Pure Food and Drug Act is passed by Congress on June 30 and signed by President
More informationPutting the Nutritional Supplement Industry to the Test: Looking for Transparency
Putting the Nutritional Supplement Industry to the Test: Looking for Transparency Frederick H. Fern @RickFern_HB ffern@harrisbeach.com Marina Plotkin @MarinaPlotkin_HB mplotkin@harrisbeach.com Putting
More informationANDA 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 informationOver the Counter Hearing Aids:
Over the Counter Hearing Aids: A deeper dive into the OTC Hearing Aid Act of 2017 Michael Scholl Director of Government and Community Relations Director of Government and Community Relations OTC Legislation
More informationDetermining Whether A Dietary Supplement Study Requires an Investigational New Drug (IND)
Determining Whether A Dietary Supplement Study Requires an Investigational New Drug (IND) 02/02/16 description Does a study that claims their dietary supplement promotes healthy joints and cartilage or
More informationSHOULD NUTRITIONAL PRODUCTS BE EVALUATED AND REIMBURSED IN THE SAME WAY PHARMACEUTICALS ARE? Issue Panel Session (IP25) 14 th November 2018
SHOULD NUTRITIONAL PRODUCTS BE EVALUATED AND REIMBURSED IN THE SAME WAY PHARMACEUTICALS ARE? Issue Panel Session (IP25) 14 th November 2018 Outline Issue panel session Nutrition Economics Challenges &
More informationPrimer: Medical Device User Fee Amendments Han Zhong l September 2011
Primer: Medical Device User Fee Amendments Han Zhong l September 2011 Introduction The Medical Device User Fee and Modernization Act (MDUFMA or MDUFA) is a set of agreements between the Food and Drug Administration
More informationNORTH AMERICAN DIETARY SUPPLEMENTS
NORTH AMERICAN DIETARY SUPPLEMENTS Prepared by: CPL Business Consultants The Manor House, Howbery Park, Wallingford, Oxfordshire, OX10 8BA Tel: +44 1491 822 844, info@cplconsult.com, www.cplconsult.com
More informationDietary Supplement Health and Education Act of 1994 Public Law rd Congress
Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements,
More informationMedical 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 informationAn Economic Framework to Inform the Scheduling of Medicines
An Economic Framework to Inform the Scheduling of Medicines Dr Bonny Parkinson Senior Research Fellow Centre for the Health Economy Dr Mutsa Gumbie Research Fellow Dr Henry Cutler Director Special thanks
More informationClient Alert. FDA Draft Guidance Broadens New Dietary Ingredient Definition and Extends Notification Requirements 1
Contact Attorney Regarding This Matter: Emalee G. Murphy 202.677.4052 - direct 202.677.4053 - fax emalee.murphy@agg.com Attorneys at Law 171 17th Street NW Suite 2100 Atlanta, GA 30363-1031 404.873.8500
More informationOverview Consumer Health Products Law and Compliance Issues
Overview Consumer Health Products Law and Compliance Issues The First Asia Pacific Pharmaceutical Compliance Congress September 2011 CHONG JIN NG Assistant General Counsel Asia Shared Legal Services Consumer
More informationAre You Considering Using CAM?
Are You Considering Using CAM? Decisions about your health care are important including decisions about whether to use complementary and alternative medicine (CAM). The National Center for Complementary
More informationMark M. Yacura. Partner
Mark M. Yacura Partner Mark M. Yacura focuses his practice primarily on FDA legal and regulatory matters. He has practiced in this area for more than 30 years. He represents his clients before administrative
More informationOverhauling 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 informationRESOLUTION OF THE STATE GREAT KHURAL OF MONGOLIA. 11 October 2002 No: 68 Ulaanbaatar. Adoption of the Government Policy on Drugs
Translation from Mongolian RESOLUTION OF THE STATE GREAT KHURAL OF MONGOLIA 11 October 2002 No: 68 Ulaanbaatar Adoption of the Government Policy on Drugs The State Great Khural of Mongolia RESOLVES: 1.
More informationThe Safety and Effectiveness of Dietary Supplements
Assignment 4 The Safety and Effectiveness of Dietary Supplements In Depth: Supplements Supplements, according to the FDA, are a product containing ingredients like vitamins, minerals, herms, amino acids,
More informationBorder Issues and Statistics: Regulatory Activities. Mr. Robert Deininger Southwest Import Director AFDO San Antonio, Texas
Border Issues and Statistics: Regulatory Activities Mr. Robert Deininger Southwest Import Director AFDO San Antonio, Texas U.S. Food & Drug Administration Mission Statement The Food & Drug Administration
More informationIDENTIFICATION OF OPPORTUNITIES FOR SACCHAROMYCES
IDENTIFICATION OF OPPORTUNITIES FOR SACCHAROMYCES BOULARDII Prepared by: CPL Business Consultants CAB International Centre, Wallingford, Oxfordshire, OX10 8DE Tel: +44 1491 829 346, info@cplconsult.com,
More informationFDA REGULATION OF DIETARY SUPPLEMENTS AND FOODS
FDA REGULATION OF DIETARY SUPPLEMENTS AND FOODS Presented by W. Patrick Noonan And Chris Noonan For NUTRITION INDUSTRY ASSOCIATION W. Patrick Noonan, P.C. 21800 Oxnard Street, Suite 840 Woodland Hills,
More informationFood Labeling: Policy Rationale IFT Food Policy Impact, 2011
Food Labeling: Policy Rationale IFT Food Policy Impact, 2011 Barbara O. Schneeman, Ph.D. Office of Nutrition, Labeling and Dietary Supplements CFSAN-FDA General Labeling Provisions FDA s authority to regulate
More informationREGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011.
REGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011. CHAPTER I Scope and definitions. Article 1 Scope.
More informationComments 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 informationThe Challenges in Developing and Commercializing HIV Tests that are Useful in Differentiating VISP/R VISP/R Workshop Bethesda, MD March 2013
The Challenges in Developing and Commercializing HIV Tests that are Useful in Differentiating VISP/R VISP/R Workshop Bethesda, MD March 2013 Christopher Bentsen, M.S.,RAC, FRAPS Bio-Rad Laboratories, Redmond,
More informationSlide 1. International Operations update. Mike Doustdar EVP International Operations. YASMIN FIEDLER, Germany Yasmin has type 1 diabetes
Slide 1 International Operations update Mike Doustdar EVP International Operations YASMIN FIEDLER, Germany Yasmin has type 1 diabetes Slide 2 Forward-looking statements Novo Nordisk s reports filed with
More informationFood and Drug Regulations - Project Number Schedule F
Graham Spry Building 250 Lanark Avenue Address Locator: 2005D Ottawa, Ontario K1A 0K9 09-128254-482 Provincial and Territorial Deputy Ministers of Health Provincial and Territorial Drug Program Managers
More informationThe Path to U.S. Market for Functional Food Ingredients
The Path to U.S. Market for Functional Food Ingredients American College of Nutrition Symposium Morristown, New Jersey November 18, 2011 DIANE B. McCOLL Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street,
More informationResidual Solvents: FDA/ Regulatory Perspective
Rosa Motta Compliance Officer Residual Solvents: FDA/ Regulatory Perspective PDA/USP Residual Solvents Conference January 18-19, 2007 1 Outline Laws and regulations governing the compliance requirements
More informationFDA 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 informationCannabis use carries significant health risks, especially for people who use it frequently and or/begin to use it at an early age.
Background: The Centre for Addiction and Mental Health (CAMH) released recommendations for the Legalization of Marijuana (with restrictions and regulations) on October 8, 2014. Addiction Services of Thames
More information4/26/2013. Libia Lugo Drug Specialist San Juan District Office Investigations Branch
Libia Lugo Drug Specialist San Juan District Office Investigations Branch The Food and Drug Administration (FDA) responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico,
More informationCompare Results. 153 Replacements 26 Insertions 344 Deletions. Total Changes. Styling and. Content. 0 Annotations. Old File: New File:
3/1/2019 4:12:31 PM Compare Results Old File: Draft Guidance.pdf 20 pages (438 KB) 3/21/2018 3:55:17 PM versus New File: Final Guidance.pdf 21 pages (323 KB) 2/28/2019 11:42:05 AM Total Changes 523 Text
More informationFDA Sampling Guidance and Practices. Terri McConnell FDA/ORA/Office of Regulatory Science
FDA Sampling Guidance and Practices Terri McConnell FDA/ORA/Office of Regulatory Science Background and General Information Mission of the Food and Drug Administration (FDA) Major Laws Enforced by the
More informationThe 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 informationRe: 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 informationFood Standards should be Reviewed and Extended
Term Paper Food Standards should be Reviewed and Extended By SS 07 ANR 490 / 811 Food Regulation in the United States Michigan State University April 2, 2007 I. Introduction The U.S. Congress passed the
More informationThe Nutrition (Amendment) (EU Exit) Regulations 2018
The Nutrition (Amendment) (EU Exit) Regulations 2018 A public consultation Contents Introduction... 3 Why we are consulting... 4 Nutrition and Health Claims... 6 Proposals... 6 Vitamins, minerals, and
More informationPARKINSON S AND HERBAL SUPPLEMENTS ERICA MARINI, PHARMD UNIVERSITY OF UTAH NEUROLOGY
PARKINSON S AND HERBAL SUPPLEMENTS ERICA MARINI, PHARMD UNIVERSITY OF UTAH NEUROLOGY OBJECTIVES What is the difference between herbal supplements, over the counter medicines, and prescription medicines?
More informationBackground EVM. FAO/WHO technical workshop on nutrient risk assessment, Geneva, May 2005, published 2006.
UK GOVERNMENT RESPONSE TO THE EUROPEAN COMMISSION S DISCUSSION PAPER ON THE SETTING OF MAXIMUM AND MINIMUM AMOUNTS FOR VITAMINS AND MINERALS IN FOODSTUFFS. Background The United Kingdom (UK) Government
More informationVisionary 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 informationRe: National Bioengineered Food Disclosure Standard; Proposed Rule; Request for Comments, 83 Fed. Reg (May 4, 2018), Docket No.
VIA ELECTRONIC SUBMISSION July 3, 2018 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: National Bioengineered Food Disclosure Standard;
More informationPartnership between the government, municipalities, NGOs and the industry: A new National Alcohol Programme in Finland
Partnership between the government, municipalities, NGOs and the industry: A new National Alcohol Programme in Finland The structure and the aims of the National Alcohol Programme Marjatta Montonen, Programme
More informationGlobal Regulation of Food Additives
Chapter 1 Global Regulation of Food Additives Downloaded via 148.251.232.83 on January 28, 2019 at 18:43:58 (UTC). See https://pubs.acs.org/sharingguidelines for options on how to legitimately share published
More informationOrnsurang Teerawat
ASEAN TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS REGULATORY AND HARMONIZATION UPDATE Ornsurang Teerawat 21.10.2014 \ http://trainstudenytp.wordpress.com ACCSQ (ASEAN Consultative Committee for Standard
More informationNatural Health Product Raw Material Policy
Natural Health Product Raw Material Policy Natural Health Products Directorate Health Products and Food Branch October 2006 Health Canada is the Federal department responsible for helping Canadians maintain
More informationmemorandum Venable s FDA Practice Group FDA Publishes Draft Guidance on New Dietary Ingredients ( NDIs )
memorandum TO Valued Dietary Supplement Clients DATE July 5, 2011 FROM Venable s FDA Practice Group RE FDA Publishes Draft Guidance on New Dietary Ingredients ( NDIs ) On July 1, 2011, the U.S. Food and
More informationTOBACCO PRODUCT OR MEDICAL PRODUCT?
TOBACCO PRODUCT OR MEDICAL PRODUCT? Priscilla Callahan-Lyon, MD Deputy Director Division of Individual Health Science Office of Science, CTP Grail Sipes, JD Director Office of Regulatory Policy, CDER Disclaimer:
More informationFood Additives Program
U.S. FDA s Food Additive Program: An Update on Resources and Challenges 18 th Food Packaging Law Seminar October 11, 2017 Arlington, VA 1 Food Additives Program Dennis Keefe, PhD Director, Office of Food
More informationAlcohol marketing: Overview of the landscape
Alcohol marketing: Overview of the landscape David H. Jernigan PhD Center on Alcohol Marketing and Youth Department of Health, Behavior and Society Johns Hopkins Bloomberg School of Public Health Alcohol
More informationA Family Medicine Cabinet
A Family Medicine Cabinet What is a medicine? There is no generally accepted definition for the word medicine. Most people use the word medicine to refer to products that affect how the body functions.
More informationThe Krakow Declaration on Iodine
The Krakow Declaration on Iodine Tasks and Responsibilities for Prevention Programs Targeting Iodine Deficiency Disorders The EUthyroid Consortium Short running title: Krakow Iodine Declaration of the
More informationVia RE: 2014 Draft National Food Safety Standard General Standard for Sports Nutrition Food
December 19, 2014 Li Bin, Chairperson National Health and Family Planning Commission 国家卫生和计划生育委员会 State Council 14 Zhichun Road Beijing 100088 The People s Republic of China (P.R.C.) China Food and Drug
More informationClass 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 informationThe Tool-Kit includes six core vitamin D intake variables and five ancillary vitamin D intake variables:
Page 1 of 7 Pediatric MS Tool-Kit Variables The Tool-Kit vitamin D intake variables were selected and defined to address the following research question: Everything else being equal, are children with
More informationNutritional Criteria for Labeling Claims
Nutritional Criteria for Labeling Claims Barbara O. Schneeman, Ph.D. Office of Nutrition, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition/ Food and Drug Administration Department
More informationCARD/MAIL/PRE-APPROVAL/PREFERRED RIDER FOR PRESCRIPTION DRUG [INSURANCE] [Policy]holder: Group Policy No: Effective Date:
RIDER FOR PRESCRIPTION DRUG [INSURANCE] [Policy]holder: Group Policy No: Effective Date: CARD/MAIL/PRE-APPROVAL/PREFERRED The Prescription Drug Coverage under this Rider [replaces] [supplements] the Prescription
More informationM I L L E R T H O M S O N LLP Barristers & Solicitors, Patent & Trade Mark Agents
M I L L E R T H O M S O N LLP Barristers & Solicitors, Patent & Trade Mark Agents Communiqué for Health Industry Clients on the Legal Retainer Program Canada s New Natural Health Products Regulations On
More informationSeptember 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 informationTeva Pharmaceuticals USA Attention: Scott D. Tomsky Vice President, US Generics Regulatory Affairs 425 Privet Road Horsham, PA 19044
DEPARTMENT OF HEALTH & HUMAN SERVICES ANDA 090783 Food and Drug Administration Silver Spring, MD 20993 Teva Pharmaceuticals USA Attention: Scott D. Tomsky Vice President, US Generics Regulatory Affairs
More informationU.S. Requirements for Dietary Supplement Ingredients and USP <2232> Elemental Impurities Is Your Company Ready for Implementation?
U.S. Requirements for Dietary Supplement Ingredients and USP Elemental Impurities Is Your Company Ready for Implementation? Priscilla Zawislak NIA-West, Ojai, CA May 28, 2015 1 Outline Ø U.S. Regulatory
More informationTest Bank for Basic Pharmacology for Nurses 14th edition by Clayton, Stock and Harroun
Test Bank for Basic Pharmacology for Nurses 14th edition by Clayton, Stock and Harroun Link download full: https://digitalcontentmarket.org/download/testbank-for-basic-pharmacology-for-nurses-14thedition-by-clayton-stock-harroun
More informationWTO THEMATIC SESSION ON REGULATORY COOPERATION BETWEEN MEMBERS 9 NOVEMBER 2016 Codex Food Labelling Standards an Overview.
WTO THEMATIC SESSION ON REGULATORY COOPERATION BETWEEN MEMBERS 9 NOVEMBER 2016 Codex Food Labelling Standards an Overview Codex Secretariat Background Codex texts are recommendations for governments to
More informationFDLI ANNUAL CONFERENCE May 4, 2018
FDLI ANNUAL CONFERENCE May 4, 2018 DIETARY SUPPLEMENTS RETAILER ISSUES AND LIABILITY Jean Frydman, Partner, Chair FDA Practice Fox Rothschild, LLP FDA Concern is Safety Only DHSEA Act of 1994 Know what
More information2/17/2018. Prof. Steven S. Saliterman Department of Biomedical Engineering, University of Minnesota
Department of Biomedical Engineering, University of Minnesota http://saliterman.umn.edu/ FDA Authority Medical Device Act of 1976 FDA Modernization Act of 1997 Federal Food, Drug and Cosmetic Act (FFDCA)
More informationProf. Steven S. Saliterman. Department of Biomedical Engineering, University of Minnesota
Department of Biomedical Engineering, University of Minnesota http://saliterman.umn.edu/ FDA Authority Medical Device Act of 1976 FDA Modernization Act of 1997 Federal Food, Drug and Cosmetic Act (FFDCA)
More informationA high-level overview of the requirements of medical packaging standards
Medical Packaging A high-level overview of the requirements of medical packaging standards Dec 2012 Thierry Wagner Regulatory Affairs Director Europe, Middle East and Africa DuPont Medical & Pharmaceutical
More informationBruce Wilkinson. Formulary & Benefit (F&B) Copay Summary Recommendation
Bruce Wilkinson Formulary & Benefit (F&B) Copay Summary Recommendation F&B Summary Copay Usage Goal: Use the Summary Copay files in a consistent manner with other F&B file types, specifically formulary
More informationOver-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 informationAgency Information Collection Activities; Submission for Office of Management and Budget
This document is scheduled to be published in the Federal Register on 01/28/2016 and available online at http://federalregister.gov/a/2016-01690, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationDIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 31 March 2004
30.4.2004 Official Journal of the European Union L 136/85 DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products,
More informationDecember 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 informationIN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION
Case 1:13-cv-03675-WBH Document 14 Filed 01/07/14 Page 1 of 9 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION UNITED STATES OF AMERICA, Plaintiff, v. CIVIL ACTION
More informationFDA Foods Program Update
FDA Foods Program Update Comments by Stephen F. Sundlof, D.V.M., Ph.D. Director Center for Food Safety and Applied Nutrition JIFSAN Annual Meeting, College Park, MD March 25, 2010 The Food Safety Working
More informationPlanning For The FDA s 'Deeming Rule' For E- Cigarettes
Law360, New York (September 21, 2015, 3:39 PM ET) -- The 2009 Family Smoking Prevention and Tobacco Control Act (TCA)[1] gave the U.S. Food and Drug Administration the authority to oversee the manufacture,
More informationAcquisition of Novartis Influenza Vaccines Business. 27 th October 2014
1 Acquisition of Novartis Influenza Vaccines Business 27 th October 2014 2 Legal Notice Forward looking statements The materials in this presentation speak only as of the date of these materials, and include
More information2. food groups: Categories of similar foods, such as fruits or vegetables.
Chapter 2 Nutrition Guidelines: Tools for a Healthy Diet Key Terms 1. nutrient density: A description of the healthfulness of foods. 2. food groups: Categories of similar foods, such as fruits or vegetables.
More informationStatement of AHEAD The Alliance for Health Economic and Agriculture Development. Concerning The Need for FDA Regulation of Tobacco Products
Statement of AHEAD The Alliance for Health Economic and Agriculture Development Concerning The Need for FDA Regulation of Tobacco Products Before the Senate Committee On Health, Education, Labor and Pensions
More informationFSMA & The Dietary Supplements Industry
FSMA & The Dietary Supplements Industry Overview FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) Foreign Supplier Verification Programs (FSVP) Produce Verification activities
More informationUSP Perspective on Atypical Actives November 29, 2017
USP Perspective on Atypical Actives November 29, 2017 USP Excipients Stakeholder Forum USP Perspective on Atypical Actives Catherine Sheehan, M.S., M.S. Senior Director, Science Excipients Outline Role
More informationon the advertising of medicinal products for human use
30. 4. 92 Official Journal of the European Communities No L 113 / 13 COUNCIL DIRECTIVE 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use THE COUNCIL OF THE EUROPEAN COMMUNITIES,
More information15 years of the European Union s Food Supplement Directive
15 years of the European Union s Food Supplement Directive Food Supplements Directive (46/2002) Recital 3 An adequate and varied diet could, under normal circumstances, provide all necessary nutrients
More informationFDA s Nutrition Innovation
FDA s Nutrition Innovation Strategy Douglas Stearn Deputy Director for Regulatory Affairs Center for Food Safety and Applied Nutrition FDLI Food Advertising Conference September 26, 2018 FDA Food Responsibilities
More informationEuropean Food Safety Authority
AF 01.10.2004 3a Discussion paper on Botanicals European Food Safety Authority SCIENTIFIC COMMITTEE Brussels, 25 June 2004 EFSA/SC/26 Final Discussion Paper on Botanicals and Botanical Preparations widely
More informationOfficial Journal of the European Union REGULATIONS
L 259/2 REGULATIONS COMMISSION DELEGATED REGULATION (EU) 2017/1798 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional
More informationAPPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 34 th EDITION THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. U.S. DEPARTMENT
More informationDeveloping a Target Product Profile for a Preventive HIV Vaccine
Developing a Target Product Profile for a Preventive HIV Vaccine Topics to be Covered Overview of TPPs What are they? What is the purpose and benefit of using a TPP? What is usually in a TPP? What are
More information