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FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.
FDA has released two guidance documents relating to the submission of abbreviated new drug applications (ANDAs). In the guidance documents, FDA explains requirements in regards to the Generic Drug User Fee Amendments of 2012 (GDUFA).
Guidance for Industry, ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA, explains how the performance metric goals established as part the GDUFA apply to ANDAs to assist applicants preparing to submit to FDA amendments to ANDAs or prior approval supplements (PASs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
The guidance describes the Tier system for the different types of amendments and the request for reconsideration process for FDA classification decisions. The guidance explains how different types of amendments may affect the application’s original review dates, as well as FDA’s performance metric goals based on the different amendment Tiers and the process for submitting amendments.
FDA states that the finalized guidance will replace the December 2001 Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications guidance in consideration of the new amendment review Tier system and performance goals under GDUFA.
The second guidance, ANDA Submissions—Prior Approval Supplements Under GDUFA, Draft Guidance, explains how the GDUFA relates to PAS submissions. FDA intends for the guidance to assist applicants preparing to submit PASs and amendments to PASs for ANDAs submitted under section 505(j) of the FD&C Act.
The guidance describes how the 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. The guidance also describes performance metric goals outlined in the GDUFA Commitment Letter and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals.