Delivery Method: Via Email Reference #: 320-25-102 Product: Drugs Recipient: Recipient Name Dr. K Suresh Babu Recipient Title Head – Corporate Quality and Regulatory Affairs Hikal […]

Docket Number: FDA-2023-D-1955 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration is […]

On This Page Date: September 11, 2025 Time: 12:30 p.m. – 3:30 p.m. ET FDA, in partnership with the Reagan-Udall Foundation, will host the sixth Online […]

Docket Number: FDA-2023-D-1954 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations for applicants […]

Docket Number: FDA-2019-D-2102 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance describes the Agency’s recommendations […]

For Immediate Release: September 05, 2025 The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) […]

[9-5-2025] The Food and Drug Administration is advising consumers not to purchase or use FTX PLUS, a product promoted and sold for joint pain on various […]

[9-5-2025] The Food and Drug Administration is advising consumers not to purchase or use REUMA KING, a product promoted and sold for joint pain on various […]

For Immediate Release: September 05, 2025 The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like […]