Federal Register notice: FDA withdraws approval of 10 NDAs from multiple applicants after they notified the agency that the drug products were no long...
FDA posts details of an Accreditation Scheme for Conformity Assessment (ASCA) pilot program that aims to enhance the predictability of the medical dev...
An FDA analysis says more ANDAs could be approved in the first cycle if sponsors ensured their applications were complete at the time of filing.
FDA medical reviewers raise questions about several aspects of an Alkermes NDA for a combination drug to treat major depressive disorder.
FDA commissioner Scott Gottlieb introduces a new Plant and Animal Biotechnology Innovation Action Plan to help ensure the safety of plant and animal b...
Due to supply shortage concerns, FDA allows two-month expiry date extensions on some epinephrine auto-injectors, 0.15 mg and 0.30 mg, distributed by I...
Federal Register notice: FDA opens a public docket to receive suggestions and comments on the agencys publication of its surrogate endpoint table.
Federal Register notice: FDAs chief scientist denies a request for a hearing on a CDER proposal to refuse approval of a Pharmaceutical Manufacturing R...