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.
A jury returns a $43 million verdict against Precision Lens for violations of the False Claims Act and Anti-Kickback Statute.
FDA warns Ponce, Puerto Rico-based Skyless LLC about CGMP, new drug, misbranding, and other violations in its production of drug products.
