FDA Updates Generic Drug Approval Process with Streamlined ANDA Submissions and Enhanced Patent Transparency.

The Food and Drug Administration (FDA) recently updated its generic drug approval process, implementing changes that impact Abbreviated New Drug Application (ANDA) submissions, the review process, and transparency regarding brand-name drug patent information. The FDA issued new guidelines for ANDA submissions, introduced a more efficient review process for generic drugs, and is facilitating easier access to information regarding the patent status of brand-name drugs for generic drug manufacturers. Specifically, the updated guidance on ANDA submissions outlines the required steps for generic drug manufacturers seeking approval. The FDA’s streamlined review process intends to expedite the approval timelines for generic drugs. Increased transparency measures aim to reduce delays in the approval process by making it easier for manufacturers to ascertain the patent status of brand-name drugs.

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Date: April 14, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後