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USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA

Center for Drug Evaluation and Research (CDER) finalized and released updated guidance on "ANDA Submissions – Prior Approval Supplements Under GDUFA" 14-October-2022.

The purpose of this guidance is to assist applicants who are preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) and to explain how the Generic Drug User Fee Amendments (GDUFA) relate to PAS submissions.

What is PAS?

A major change is a change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.

A major change requires the submission of a supplement and approval by FDA prior to distribution of the drug product made using the change. This type of supplement is called and should be clearly labeled a Prior Approval Supplement.

As a result of this guidance, the applicants will understand how the GDUFA performance goals apply to:

  • A PAS subject to the refuse-to-receive (RTR) standards

  • A PAS that requires an inspection

  • A PAS for which an inspection is not required

  • An amendment to a PAS

  • Other PAS-related matters

Click this LINK to know more about the Impact of GDUFA Performance Goals on PAS submission.


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