Guides: Food, Drug, and Cosmetic Law Research Guide: Secondary Sources

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Treatises & Texts

Federal Procedure, Lawyer's Edition: Chapter 35
Chapter 35 (Food, Drugs, and Cosmetics) of Federal Procedure provides an overview of agency procedures and citations to in-depth research references. Print (KF8835 .F43 1981) is available but updates were cancelled in 2014.
Food and Drug Administration (4th ed., updated in 2020)
This two-volume treatise by James T. O'Reilly is updated regularly and overviews the organization of the FDA, FDA enforcement procedures, as well as general overviews of relevant regulatory areas. Appendixes also include forms and tables of cases, statutes, and regulations. Print version of the 3rd edition is available (KF3871 .O7 2007).
Food and Drug Law : Federal Regulation of Drugs, Biologics, medical devices, foods, dietary supplements, personal care, veterinary and tobacco products
"This food and drug law...book is organized...in order to comprehend a complex area of federal regulatory law. There is a separate volume for each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related laws all contained in this bound book. [This book] is organized into subject specific titled volumes with a concise introduction to provide a particular focus for the reader."
Pharmaceutical Law: Regulation of Research, Development, and Marketing
This source, edited by Michael E. Clark, focuses on the complex world of pharmaceutical drugs from development to marketing. It includes a breakdown of the various processes involved, as well as discussion of relevant statutes and regulations. Older editions available in print (KF2915.P4 P495).
A Practical Guide to FDA's Food and Drug Law and Regulation
Kenneth R. Piña and Wayne L. Pines (5th ed. 2017), KF1900.Z9 P73 2017. One-volume guide published by the Food and Drug Law Institute.

The following subject headings can be used to search the library's catalog for additional relevant materials:

United States. Food and Drug Administration
Food law and legislation -- United States
Drugs -- Law and legislation -- United States
Pharmacy -- Law and legislation -- United States
Pharmaceutical industry -- United States
Drug development -- United States
Cosmetics -- Law and legislation -- United States

Law Reviews & Journals

Food and Drug Law Journal (K6 .O281) (1992-2008, 2014-2022; print subscription cancelled)

Westlaw (1989 - )
Lexis (1996 - )
HeinOnline (1946 - )

Journal of Food Law and Policy (K10.O3696) (2005-2008; print subscription cancelled)

Westlaw (2005 - )
HeinOnline (2005 - )

For information on how to search and locate relevant articles in other legal and non-legal periodicals generally, see Georgetown Law Library's Articles for Legal and Non-Legal Research Guide.

Current Awareness Sources

Pharmaceutical & Life Science News
Food & Drug Law Weekly
Drug Law Weekly
Update: Food and Drug Law, Regulation, and Education
(KF3866.3 .F44)
Published by the Food and Drug Law Institute six times per year.
FDA Consumer Magazine
(1988 - 2007)
FDA stopped publishing this magazine in 2007. Information for consumer is now available online at FDA: Consumer Updates.
FDA Consumer Updates
Food, Drug, Cosmetic Law Reporter

Food, Drug, and Cosmetic Law Research Guide

Contents

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Treatises & Texts

Law Reviews & Journals

Current Awareness Sources