Federal Register notice: FDA submits to OMB an information collection revision for Special Protocol Assessments.
FDA posts a 15-item FDA 483 issued 2/25 to Shilpa Medicare following an inspection of the firms Telangana, India drug manufacturing facility.
Federal Register notice: FDA proposes to reclassify nucleic acid-based hepatitis C virus ribonucleic acid devices intended for the qualitative or quan...
FDA warns Thailands Okamoto Rubber Products about QS violations in its manufacturing of lubricated natural rubber condoms.
FDA warns Taiwans E-Care Technology about QS and MDR violations in its production of the Swiave thermometer.
FDA grants an emergency use authorization to Cellex for a coronavirus serology test.
FDA approves a Rudy Giuliani-touted Celularity IND for its investigational stem cell therapy in Covid-19 patients.
FDA releases the FDA-483 with three observations issued following an inspection at Malaysias Biocon Sdn Bhd.