The International Council for Harmonization says its Q13 guidance on drug continuous manufacturing is available for public comment.
Federal Register notice: FDA announces the generic drug user fee rates for fiscal year FY 2022.
Federal Register notice: FDA issues a five-year debarment order against Justin Ash due to his felony conviction for illegal importation of a drug or c...
FDA issues a draft guidance to help sponsors develop anti-rabies virus monoclonal antibody cocktails.
FDA clears two Medtronic AccuRhythm artificial intelligence algorithms for use with the LINQ II insertable cardiac monitor.
FDA clears an Asensus Surgical 510(k) for its 5 mm diameter articulating instruments for use on the Senhance Surgical System technology platform.
FDA holds a Webinar to clarify agency thinking on the distinction between medical device servicing and remanufacturing and to consider cybersecurity i...
Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide.