Three stakeholders comment on an FDA draft guidance on visual inspection of injectable products for visible particulates.
FDA accepts a Mirati NDA for adagrasib to treat some lung cancers.
FDA warns Indias Indiana Chem-Port about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA warns Christiansburg, VA-based Avila Herbals about concerns in its work as a clinical investigator of an investigational drug.
Federal Register notice: FDA seeks comments on recommendations by the World Health Organization to impose international manufacturing and distributing...
FDA places a clinical hold against Legend Biotech and its Phase 1 clinical trial for LB1901, an investigational autologous CAR-T cell therapy for trea...
The U.S. Senate votes 50 to 46 to confirm Robert Califf as the next FDA commissioner.
Aspen Tech Policy Hub fellow Daniel Bardenstein says FDA should require medical device manufacturers to meet a baseline of cybersecurity protections.