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Review of AND Filing Checklist and Common Refuse to Receive Issues Johnny Young, M.A.L.A.1Overview of ANDAs2General Considerations3 AND Filing Checklist is Updated Quarterly (typically MarJunSeptDec)

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What is review of anda?

The review of abbreviated new drug application (ANDA) is a process where the Food and Drug Administration (FDA) evaluates the bioequivalence and quality of a generic version of a brand-name drug.

Who is required to file review of anda?

Any pharmaceutical company seeking approval for a generic version of a brand-name drug needs to file a review of ANDA.

How to fill out review of anda?

The review of ANDA can be filled out and submitted electronically through the FDA's Electronic Submission Gateway (ESG) or by mailing a physical copy to the FDA.

What is the purpose of review of anda?

The purpose of the review of ANDA is to demonstrate that the generic drug is bioequivalent to the brand-name drug and is safe and effective for use.

What information must be reported on review of anda?

The review of ANDA must include detailed information on the active ingredients, formulation, manufacturing process, labeling, packaging, and testing data of the generic drug.