Isomeric Pharmacy Solutions recalls all lots of sterile products compounded and packaged that remain within expiry to the hospital/user level due to F...
Philips Healthcare recalls its Mobile Diagnostic X-Ray System with Digital Panel due to a software design issue.
FDA tells Repros Therapeutics that a partial clinical hold will continue against Proellex (telapristone acetate) and its use in treating uterine fibro...
FDA and other regulatory bodies participating under the International Medical Device Regulators Forum post a final guidance document on IMDRF Terminol...
FDA Review posts latest Federal Register for the week ending 4/7/2017.
FDA issues Merck a complete response letter on supplemental NDAs for sitagliptin-containing drugs that sought to add labeling based on results from TE...
CDRH officials provide their viewpoint on differing clinical trial considerations in producing data to justify marketing approval or clearance.
A United Therapeutic Corp. petition asks FDA not to approve a generic copy of Tyvasco (treprosrinil) if it determines that the proposed generic device...