A bipartisan group of 11 Senate and House members asks FDA to require hearing aid labeling to disclose if the device uses proprietary software that af...
The International Council on Harmonization publishes the M12 final guideline on drug interactions and an accompanying question-and-answer document.
Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Evaluation of Automati...
Federal Register notice: FDA announces the issuance of an emergency use authorization for Invivyds Pemgarda (pemivibart) for use as Covid-19 pre-expos...
FDA warns Chinas Ostar Beauty Sci-Tech about illegally marketing unapproved medical devices.
FDA warns Charlottesville, VA-based ION Intelligence of Nature about multiple violations in its production of drugs and dietary supplements.
FDA clears a Spineart 510(k) for its Scarlet AC-Ti secured anterior cervical cage.
Teva says FDA should drop its recommendation for the use of dedicated manufacturing facilities for ezetimibe to prevent cross-contamination.
