Full text of all of the FDA regulatory requirements for food, drugs, cosmetics, and medical devices (including tentative final monographs for OTC drugs), DEA requirements for controlled substances, Consumer Product Safety Commission requirements regarding poison prevention, and U.S. Custom Service requirements for importation and export. Select from the list of FDA Regulations products below:
An invaluable resource providing everything you need to know about Food and Drug Regulations.
Your resource for comprehensive coverage of law relating to medical devices.
News Headlines |
Topic SpotlightOpioid REMS comment period reopened The FDA reopened until October 19, 2010, the comment period of a public meeting held on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. Learn More » |
Topic SpotlightPharmacologic class descriptions guidance issued A guidance to help applicants and the review staff in the FDA's Center for Drug Evaluation and Research determine when a drug belongs to an established pharmacologic class, as well as how to select the appropriate word, phrase, or term that describes the pharmacologic class for inclusion in approved prescription drug labeling was issued by the FDA. Learn More » |
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