FDA issues a report on steps it has taken to integrate alternative approaches into regulatory programs.
Federal Register notice: FDA posts final guidance entitled Mouse Embryo Assay for Assisted Reproduction Technology Devices.
FDA issues a safety alert about false negatives with KorvaLabs Curative SARS-Cov-2 (Covid-19) test.
FDA commissioner Stephen Hahn and CBER director Peter Marks strongly urge healthcare providers not to unilaterally alter the FDA-authorized dosing sch...
FDA releases its latest batch of Warning Letters that include Cocos Holistic Specialties & Apothecary and Reddy Naturals.
FDA issues a guidance with the latest provisions of the Q-Submission program for medical devices agreed to under MDUFA 4.
FDA releases the FDA-483 with two observations issued following an inspection at OSO Biopharmaceuticals Manufacturing.
Bristol-Myers Squibb decides to end its Opdivo development program for treating some brain cancer patients.