A Senate bipartisan bill aims to close a loophole that pharmaceutical companies can exploit to block drug competition, including generic drugs.
FDA commissioner Robert Califf, CBER director Peter Marks, and Childrens Hospital of Philadelphia vaccine expert Paul Offit debate in the New England ...
Federal Register notice: FDA cancels for undisclosed reasons a 3/20 joint meeting of the Nonprescription Drugs Advisory Committee and Anesthetic and A...
FDA clears a Bigfoot Biomedical 510(k) for the Android version of the Bigfoot Unity Mobile App, which is a part of the Bigfoot Unity Diabetes Manageme...
FDA clears a Noah Medical 510(k) for the Galaxy System, a robotic-navigated bronchoscopy device and accessories that are intended to provide bronchosc...
The CDER Office of Generic Drugs annual report says it approved 914 new ANDAs in 2022 and took many other steps under the GDUFA 3 reauthorization.
FDA publishes the International Council on Harmonization Q13 guidance on continuous manufacturing of drug substances and products.
FDA outlines new potential GMP issues under policy consideration in a discussion paper entitled Artificial Intelligence (AI) in Drug Manufacturing.
