On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other ar
Similar Posts
Konrad Rejdak, MD, PhD – 671405 – 05/01/2025
Bioresearch Monitoring Program/IRBFDA Embraces Radical Transparency by Publishing Complete Response Letters
The FDA today published more than 200 decision letters, known as complete response letters (CRLs).COSMO KOREA – 11/03/2025
Unapproved New Drugs/Misbranded/BotoxFace Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk
November 14, 2025, Face Rock Creamery LLC of Bandon, OR is voluntarily recalling 16/6oz. units of Vampire Slayer Garlic Cheddar with a use-by date of 11/04/26 because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infectioPDUFA VIII: Fiscal Years 2028 – 2032
Information related to FDA’s preparation for the seventh reauthorization of PDUFA.FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary
