FDA moves to blunt criticism of the Commissioners National Priority Voucher Program with a news release containing 18 questions and answers, making th...
FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.
FDA and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.
FDA approves changes to the isotretinoin REMS to take effect in 180 days.
FDA issues a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the companys Houston facility...
FDA accepts for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type 1.
FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the companys use of a Prio...
FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because ...
