Tivdak (tisotumab vedotin-tftv) Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy 9/20/2021 4/29/2024 Elahere (mirvetuximab soravtansine-gynx) Adult […]

On April 29, 2024, the Food and Drug Administration granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.  [now a part of Pfizer Inc.]) for recurrent […]

2024 2023 2022 2021 2020 2019 Understanding the Change Log Welcome to the Quarterly IID Change Log. FDA publishes the IID on a quarterly basis. The […]

The 2023 OND Annual report captures the office’s achievements, including notable drug approvals, guidances, publications, and staff’s involvement in public meetings, workshops, webinars, and conferences. This […]

Several times a year the Center for Drug Evaluation and Research sends out an update to share information on new developments, opportunities, and initiatives in regulatory […]

The Role of Scientific Consortia in Drug Development Background Information The Critical Path Initiative (CPI), and the Strategic Plan for Advancing Regulatory Science Initiative seek to […]

For Immediate Release: April 26, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Address for Regulatory Submissions Food and Drug Administration,Center for Drug Evaluation and Research,Division of XXXXX,5901-B Ammendale Road,Beltsville, MD 20705-1266. Investigational New Drug (IND) Applications Therapeutic Biological […]

There are two regulatory pathways to bring a nonprescription drug to market in the U.S. — the drug application process and Over-the-Counter (OTC) Drug Review (OTC […]