In 2023, the FDA continued to apply its rigorous review process for generic drug approvals and approved or tentatively approved 956 ANDAs including 90 first generics. The Office of Generic Drugs 2023 Annual Report provides a comprehensive look at what the agency accomplished in 2023 and how it is well-positioned to continue this critical work in 2024.
FDA Science, Research, and Collaboration Advance Generic Medicines
In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products.
FDA Enhances Global Patient and Regulatory Collaborations in Oncology
Feb. 1 Virtual Discussion to Highlight Successes from Development to Approval