Healthy Skepticism Library item: 11921

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Food and Drug Administration, HHS.
Applications for Food and Drug Administration application approval to market a new drug; revision of postmarketing reporting requirements. Final rule
Fed Regist. 2007 Oct 18; 72:(201):58993-9000
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=PubMed&Cmd=ShowDetailView&TermToSearch=17966558

Abstract:

The Food and Drug Administration (FDA) is amending its regulations describing postmarketing reporting requirements to implement certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The changes apply to drug products that are life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition and that were not originally derived from human tissue and replaced by a recombinant product. The final rule implements provisions of the Modernization Act by requiring an applicant who is the sole manufacturer of one of these products to notify FDA at least 6 months before discontinuing manufacture of the drug product.

Keywords:
MeSH Terms: Documentation Drug Approval*/legislation & jurisprudence Drug Industry*/legislation & jurisprudence Humans Information Services/legislation & jurisprudence Product Surveillance, Postmarketing* United States United States Food and Drug Administration