Wednesday, January 26, 2022

FDA Issues Series of Guidances Under Drug Competition Action Plan - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Issues Series of Guidances Under Drug Competition Action Plan

This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review. These guidances are part of our continued efforts to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to the medicines they need at affordable prices. Bringing more competition to the market and addressing the high costs of medicines are top agency priorities.

These guidances support FDA's Drug Competition Action Plan (DCAP), which encourages robust and timely market competition for generic drugs. Offering clarified, up-to-date guidance for industry demonstrates FDA's commitment to bringing more high-quality, safe, effective, and affordable generic medicines to all consumers.

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