FDA issues contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firms Bloomington, IN facil...
FDA clears a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor system for expanded use in pediatric patients over the age of two years who h...
FDA lifts a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for treating people with ...
FDA says its inspections in India are nearing pre-pandemic levels.
CDER associate director Theresa Mullin says FDA will soon release a draft guidance on Incorporating Clinical Outcome Assessments into Endpoints for Re...
Harvard Medical School researchers call for a reinvigoration of the Park doctrine holding corporate officers personally liable for misconduct by drug ...
FDA warns Scottsdale, AZ-based BioLab Sciences it is illegally marketing drug and biologic products that have been produced with significant CGMP viol...
FDA medical reviewers tell the Oncologic Drugs Advisory Committee there are significant questions about Spectrum Pharmaceuticals proposed lung cancer ...
