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Circulars Circular No. 2022-004-A

Amendment to FDA Circular No. 2022-004 entitled "Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals" to include Generic Drug Registration Applications and update the list of Reference Drug Regulatory Agencies

Food and Drug Administration

Issued 2023-02-15 Filed 2023-02-16 ONAR 24-00195