Docket Number: FDA-2022-D-3054 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food […]

Docket Number: FDA-2022-D-3054 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food […]

Summary Company Announcement Date: June 02, 2025 FDA Publish Date: June 04, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: […]

INNOVATION   PREDICTABILITY   ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2023 Table of Contents Director’s Message Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research Welcome […]

Docket Number: FDA-2025-D-1358 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously […]

As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year. Original and PAS Review   Review Time Goal Actions […]

3/22/2024 Pemgarda (220 KB) (reissued April 3, 2024 and August 26, 2024) Letter Granting EUA Amendment (May 17, 2024) (219 KB) Letter Granting EUA Amendment (September 26, 2024) […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-68 Product: Drugs Recipient: Recipient Name Mr. Roland Holmqvist Recipient Title Chief Executive Officer Rechon Life Science […]