Bioavailability and bioequivalence requirements: abbreviated applications. Final Rule.
The Food and Drug Administration (FDA) is amending 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.
D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D006207:Half-Life; D006801:Humans; D007880:Legislation, Drug; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration