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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).
Enforcement Databases: Login to search three comprehensive databases of FDA Warning Letters, Cyber Letters and DDMAC Untitled Letters. Available to subscribers to FDA Enforcement Manual and FDA Advertising and Promotion Manual.
clinlaw: The online database of state and federal clinical trial requirements. Available with a subscription to the Guide to Good Clinical Practice.
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