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Page 1: A Practical Guide to FDA’s Food and Drug Law and …A Practical Guide to FDA’s Food and Drug Law and Regulation Sixth Edition Edited by Kenneth R. Piña and Wayne L. Pines FOOD

A Practical Guide to FDA’s Food and Drug Law and Regulation Sixth EditionEdited by Kenneth R. Piña and Wayne L. Pines

FOOD AND DRUG LAW INSTITUTE1155 15th Street NW, Suite 910Washington, DC 20005p: [email protected]

A Practical G

uide to FDA’s Food and D

rug Law and Regulation, Sixth Edition I Edited by Kenneth R. Piña and W

ayne L. Pines

Page 2: A Practical Guide to FDA’s Food and Drug Law and …A Practical Guide to FDA’s Food and Drug Law and Regulation Sixth Edition Edited by Kenneth R. Piña and Wayne L. Pines FOOD

Contents

Introduction ............................................................................................................................................................ v

About the Editors ................................................................................................................................................vii

About the Authors ............................................................................................................................................... ix

Chapter 1 .................................................................................................................................................................. 1Overview of the U.S. Legal System Edward P. Richards, III, J.D., M.P.H., Director, Program in Law, Science, and Public Health, and

Clarence W. Edwards Professor of Law, Louisiana State University Law Center, Baton Rouge, LA Chapter 2 ...............................................................................................................................................................19U.S. Food and Drug Law and FDA—A Historical Background Paul Hyman, Hyman, Phelps & McNamara, PC, Washington, D.C.

Chapter 3 ...............................................................................................................................................................67The Philosophy of Food and Drug Law Richard M. Cooper & Benjamin M. Greenblum, Williams & Connolly LLP, Washington, D.C.

Chapter 4 ...............................................................................................................................................................91The Food and Drug Administration—How It Is Organized and Works Fred H. Degnan & Smitha Stansbury, King & Spalding, LLP, Washington, D.C.

Chapter 5 ............................................................................................................................................................. 125The Drugs/Biologics Approval Process Geoffrey M. Levitt, Pfizer Inc, New York, NY

Chapter 6 ............................................................................................................................................................ 179A Pharmacovigilance Primer Edward John Allera, Genevieve M. Spires, Tina Hu-Rodgers, & Alexandre Gapihan, Buchanan

Ingersoll & Rooney PC, Washington, D.C.

Chapter 7 ............................................................................................................................................................. 193Approval of New Animal Drugs Joseph W. Cormier, J.D., Ph.D., Hyman, Phelps & McNamara, PC, Washington, D.C.

Chapter 8 ............................................................................................................................................................. 211The Medical Device Approval Process Steve Kanovsky, GE Healthcare, Waukesha, WI and Edward C. Wilson, Jr. &

Michael S. Heyl, Hogan Lovells US LLP, Washington, D.C.

Chapter 9 ............................................................................................................................................................. 249Combination Products Suzanne O’Shea, Paula Gray, Sarah Baumann, Gina LaBella Tulin, Dorothy Henckel, &

Miles Johnson, all of Navigant Consulting, Chicago, IL

FDLI_Practical_Guide_FM.indd 3 8/19/17 1:06 PM

Page 3: A Practical Guide to FDA’s Food and Drug Law and …A Practical Guide to FDA’s Food and Drug Law and Regulation Sixth Edition Edited by Kenneth R. Piña and Wayne L. Pines FOOD

iv

Chapter 10 ........................................................................................................................................................ 275The Cosmetics Regulatory Process Thomas F. Myers, Personal Care Products Council, Washington, D.C.

Chapter 11 .......................................................................................................................................................... 295The Regulation of Foods and Food Additives Daniel A. Kracov & Raqiyyah R. Pippins, Arnold & Porter Kaye Scholer LLP, Washington, D.C.

Chapter 12 ......................................................................................................................................................... 361The Regulation of Dietary Supplements James William Woodlee, Cynthia L. Meyer & Anthony L. Young, Kleinfeld, Kaplan and Becker,

LLP, Washington, D.C.

Chapter 13 ......................................................................................................................................................... 387FDA Regulation of Tobacco Products Joseph A. Page, Georgetown University Law Center, Washington, D.C.

Chapter 14 .......................................................................................................................................................... 439Regulation of Promotion and Distribution Wayne L. Pines, APCO Worldwide Inc., Washington, D.C. Chapter 15 .......................................................................................................................................................... 467Review of FDA Inspections and Related Regulations Ronald F. Tetzlaff, Ph.D., PAREXEL Consulting, Duluth, GA & David L. Chesney,

DL Chesney Consulting, LLC, Exeter, NH Chapter 16 .......................................................................................................................................................... 505FDA Enforcement: How It Works Vernessa T. Pollard, Partner, & Anisa Mohanty, Associate, McDermott Will & Emery,

LLP, Washington, D.C.

Chapter 17 .......................................................................................................................................................... 541Managing an FDA Regulatory Crisis William Vodra, Retired Partner, Arnold & Porter Kaye Scholer LLP, Washington, D.C. &

Wayne L. Pines, APCO Worldwide Inc., Washington, D.C.

Chapter 18 .......................................................................................................................................................... 555Research and the FDA Gary L. Yingling, J.D., B.S.Pharm., M.S., & Ann M. Begley, J.D., B.S.N., Morgan Lewis,

Washington, D.C.

Chapter 19 .......................................................................................................................................................... 567International Regulation Sam Halabi, The University of Missouri School of Law, Columbia, MO & Richard Kingham,

Covington & Burling LLP, Washington, D.C.

Index ..................................................................................................................................................................... 581

A PrActicAl GuidE to FdA’S Food And druG lAw And rEGulAtion, SiXtH Edition

FDLI_Practical_Guide_FM.indd 4 8/19/17 1:06 PM


Food: Medical Foods: FDA’s Guidance, Substantiation Standards, and … · 2016-12-07 · Enforcement, Litigation, and Compliance Conference December 7-8, 2016 Washington, DC Food:

GAO-16-399, Imported Food Safety: FDA’s Targeting Tool Has

FSMA: A Foreign Suppliers Guide Webinar Slides.pdf · processing, packing, or holding of “food” Raw materials and ingredients are “food” • According to FDA’s historical

Major Components of FDA’s Action Plan for Acrylamide Richard Canady, PhD DABT US Food and Drug Administration Center for Food Safety and Applied Nutrition

NGFA Country Elevator Conference · Presentation Outline • Food Safety Modernization Act • FDA’s Authority to Regulate the U.S. Food ... May 31, 2016: Sanitary Transportation

Practical english food

FDA’s PV Guidance

FDA’S PACIFIC REGION RETAIL FOOD SEMINAR SEPTEMBER 23-24, 2015 JOHN BURR OREGON DEPARTMENT OF AGRICULTURE FOOD SAFETY PROGRAM

Framework for FDA’s

FDA’s Gluten-Free Food Labeling Rulemaking · 2015-06-22 · 1 FDA’s Gluten-Free Food Labeling Rulemaking Global Issues and Impact of Gluten Allergy and Celiac Disease Symposium

Use of the Term “Natural” in Food Labeling FDA’s Perspective · 2019-11-21 · Use of the Term “Natural” in Food Labeling FDA’s Perspective Patricia A. Hansen, PhD Deputy

Food Hygiene Unit 1: Food Inspection Topic: Inspection of food items Practical 7

Pages Food Chain 24 - Practical Action

Practical Ecology Ecosystems and Food Chains

Food Allergies - Oregon State University...Food Allergies What You Need to Know FDA’s Role: Labeling To help Americans avoid the health risks posed by food allergens, Congress passed

Challenges Remain in FDA’s Inspections of Domestic … of Health and Human Services OFFICE OF INSPECTOR GENERAL CHALLENGES REMAIN IN FDA’S INSPECTIONS OF DOMESTIC FOOD FACILITIES

Fda’s warning on_ortiga

Toxicology Component of FDA’s Action Plan for Acrylamide Richard Canady, PhD DABT US Food and Drug Administration Center for Food Safety and Applied Nutrition

GAO-15-183, FOOD SAFETY: Additional Actions Needed to Help ... · FOOD SAFETY Additional Actions Needed to Help FDA’s Foreign Offices Ensure Safety of Imported Food ttee on Europe,

FOOD CHEMISTRY-Practical-Demo

FDA’s Revised Draft Guidance for Control of Listeria ... · June 13, 2017 Presentation for the Wisconsin Association for Food Protection FDA’s Revised Draft Guidance for Control

CHAPTER 21: Glass Inclusion - Food and Drug Administration · PDF fileCHAPTER 21: Glass Inclusion . This guidance represents the Food and Drug Administration’s (FDA’s) current

A Purposeful Engagement: FDA’s International Food Safety Capacity-Building Plan

UNDERSTANDING FDA’S FSMA RULE FOR FOOD FACILITIES · understanding fda’s fsma rule for food facilities ... august 2016. 2 understanding fda’s fsma rule for food facilities august

Insight into FDA’s Sanitary Transport and Food Defense€¦ · 01/04/2018  · Food Safety Modernization Act (FSMA) PL 111-353, 124 Stat. 3885. ... Animal Food: What You Need to

Fda’s food grade guar gum powder evaluation

Practical Food Safety

Food Chain 29 - Practical Action

UNDERSTANDING FDA’S FSMA RULE FOR FOOD FACILITIESThe Food Safety Modernization Act (FSMA), signed into law in January 2011, authorizes the U.S. Food and Drug Administration (FDA)

NOT READY FOR TIME...NOT READY FOR PRIME TIME: FDA’s Flawed Approach To Assessing The Safety Of Food From Animal Clones Executive Summary 1 Introduction and Background 3 FDA’s

Rethinking FDA’s Food and Supplement Framework:

FDA’s Pharmaceutical Inspectorate Robert Coleman National Expert Drug Investigator Food and Drug Administration

FDA’s Clinical Investigator Course by. FDA’s CDER, Office of Medical Policy. and. The Duke University School of Medicine. FDA’s Clinical Investigator Course

GAO-16-399, Imported Food Safety: FDA’s Targeting …FDA’s Targeting Tool Has Enhanced Screening, but Further Improvements Are Possible Subcommittee on Europe, Eurasia, and Emerging

FDA’s Food Additives Program - ILSI India › Food_Additives_Global_Perspective_on... · 2018-08-02 · Why We Regulate Federal Food Drug and Cosmetic Act. Sec. 201(s) Food Additives