FDA released final guidance on preparing and submitting amendments to tentatively approved ANDAs and requests for final approval. It provides recommendations on the timing and content of amendments that could facilitate final approval on the “earliest lawful ANDA approval date,” which is based on patent and/or exclusivity protections. The guidance includes a list of common developments, such as updates on product quality, labeling, and exclusivity that may require an amendment to ensure that applications are complete and up-to-date.
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