Federal Register notice: FDA has submitted to OMB an information collection extension entitled Guidance for Industry: Drug Supply Chain Security Act I...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for InSightecs medical device Exablate.
Federal Register notice: FDA seeks comments on an information collection extension entitled Electronic Submission of Medical Device Registration and L...
FDA approves Olympus Spiration Valve System for treating severe emphysema, a progressive form of chronic obstructive pulmonary disease.
PHRMA praises FDA for its new draft guidance on adaptive designs for clinical trials of drugs and biologics.
FDA clears a Subtle Medical 510(k) for the SubtlePET, an artificial intelligence-powered technology that the company says allows hospitals and imaging...
FDA clears a Bausch & Lomb 510(k) for its Ultra Multifocal for Astigmatism contact lens, a monthly silicone hydrogel lens.
FDA accepts for priority review a Genentech sBLA for a new indication for its Tecentriq.