Explanations, regulations, court decisions, proposals, final rules, guidance, and other news regarding the safety, effectiveness, manufacturing, labeling, packaging, and marketing of human drugs, veterinary drugs, biological products, OTC drugs, and controlled substances. Specific attention is given to generic drugs; investigational new drugs; animal feeds; blood and blood products; and human cells, tissues, and cellular and tissue-based products. Select from the list of Drugs and Biologics 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.
This book includes professional explanations of each provision of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
Contains regulations and explanations for Medicare Part D Final Rules issued by CMS.
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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