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