Bioavailability and bioequivalence requirements; abbreviated applications; proposed revisions--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to revise its regulations on bioavailability and bioequivalence and on the content and format of an abbreviated application to reflect current FDA policy and to correct certain typographical and inadvertent errors. This action is intended to improve the accuracy and clarity of the regulations.
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational