SECT 505(b)(2) has various meanings in the Administration category. Discover the full forms, definitions, and usage contexts of SECT 505(b)(2) in Administration.
A document whereby a pharmaceutical manufacturer or its agent requests permission from the United States Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications; besides a chemical and pharmacologic description of the drug, the application must show the results of clinical trials conducted with respect to the indication for which a license is requested.
AdministrationLast updated: