FDA Releases ANDA Submission Guidance

FDA published guidance on Oct. 14, 2016 explaining how the Generic Drug User Fee Amendments of 2012 (GDUFA) relates to preparing prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA also describes GDUFA performance metric goals and clarifies how the agency will handle a PAS and PAS amendments for an ANDA subject to those goals.

In the guidance, FDA describes how GDUFA performance metric goals apply to a PAS subject to the refuse-to-receive standards, a PAS that requires an inspection, a PAS for which an inspection is not required, an amendment to a PAS, and other PAS-related matters.