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 SpotlightProprietary names usage for drug products, guidance Recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary names for drugs, including biological products, and other factors that, in association with the name, can contribute to medication errors are provided in a guidance published by the agency. Learn More » |
Topic SpotlightRegulatory site visit training program announced Interested biologics facilities are invited to participate in the FDA's Center for Biologics Evaluation and Research (CBER) Regulatory Site Visit Training Program. Learn More » |
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