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 SpotlightCardiovascular risk in antidiabetic therapies; guidance The FDA released a guidance making recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. Learn More » |
Topic SpotlightOrphan product development grants available The FDA's Office of Orphan Product Development (OPD) will give grants totaling over $14 million in fiscal year (FY) 2010 for orphan product studies. The office anticipates similar funding for FY 2011. Learn More » |
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