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FDA Releases Final Guidance For Complex ANDA Meetings

The Pre-ANDA Program Guidance Has Been Revised To Bring More Clarity

Executive Summary

The FDA has released final guidance on “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA” for the industry. The guidance brings clarity and aims at facilitating product development meetings between the FDA and the ANDA applicants for complex products.

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