Summary Company Announcement Date: July 09, 2020 FDA Publish Date: July 24, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol […]

Summary Company Announcement Date: August 30, 2023 FDA Publish Date: August 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Label Mix-Up Company Name: […]

Drugs to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]

Product: Drugs Recipient: www.dashpct.com Malaysia Issuing Office: Center for Drug Evaluation and Research | CDER United States FROM: The United States Food and Drug Administration RE: […]

The Inactive Ingredients files are supplied as comma delimited text and Excel files. The size of each unzipped file is less than 2 MB. We update […]

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 […]