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  Food & Drug Regulation
Controlled Substances Handbook Controlled Substances Handbook
 FDA Enforcement Manual FDA Enforcement Manual
 FDA Advertising and Promotion Manual FDA Advertising and Promotion Manual
Guide to Good Clinical Practice Guide to Good Clinical Practice
 Guide to U.S. Food Labeling Law Guide to U.S. Food Labeling Law
 Guide to Medical Device Regulation Guide to Medical Device Regulation
Thompson’s Drug & Device Enforcement & Litigation: Impact on 2008 and Beyond New Edition Thompson’s Drug & Device Enforcement & Litigation: Impact on 2008 and Beyond New Edition
 Food Labeling Q&A Reference Manual Food Labeling Q&A Reference Manual

Interactive Training

Audio Conferences:
Clinical Trials in the Developing World: Planning, Conducting, Monitoring, Defending (Tuesday, August 03 2010)

Social Media and Online Marketing in FDA-Regulated Companies: What You Need to Know to Prepare for Upcoming FDA Guidelines (Thursday, August 05 2010)

The FDA's New "Bad Ad Program": Be Ready for Enforcement (Tuesday, August 10 2010)

Dietary Supplements and Functional Foods: What You Need to Know About 2010 Enforcement (Thursday, August 26 2010)

The FDA's New Adverse Reaction Early Warning System: How Will It Impact Your Approved Drugs and Biologics? (Tuesday, August 31 2010)

Online Products

FDA Advertising and Promotion Manual Online Edition

FDA Enforcement Manual Online Edition

Guide to Good Clinical Practice Online Edition

Guide to Medical Device Regulation Online Edition

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The Food and Drug Regulation Library provides complete, reliable information on: FDA regulation, FDA compliance and enforcement, FDA and Federal Trade Commission (FTC) advertising policies, how and why FDA conducts inspections, responding to 483s and warning letters, medical device regulation, food labeling, clinical trials of new drugs, devices, and biologics dietary supplements, pharmaceutical, food and drug law, genetically modified food labeling, nutrition labeling, nutrient content and health claims, U.S. Department of Agriculture labeling rules, country-of-origin labeling, Food and Drug Administration (FDA), FDA Modernization Act (FDAMA), Prescription Drug User Fee Act (PDUFA), biotechnology regulations, in-vitro diagnostic device (IVD) regulation, Federal Food Drug and Cosmetic Act, and good manufacturing practices (GMPs).

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