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 Works to Make Informed Consent Easier to Understand
FDA and the Office for Human Research Protections have published a draft guidance: “Key Information and Facilitating Understanding in Informed Consent.”
FDA Helps to Deliver Meaningful Advances for Rare Disease Patients
FDA’s Rare Disease Day Meeting on March 1 Dedicated to Patients and Health Care Professionals