FDA issues Mallinckrodt subsidiary SpecGx a complete response letter on its NDA for its investigational abuse-deterrent, immediate-release reformulati...
Three stakeholders generally praise FDA for its draft guidance on developing human gene therapy products to treat hemophilia.
FDAs Office of Regulatory Affairs steps up its Warning Letter issuance to pharmaceutical firms in fiscal year 2018, issuing 40% more letters.
FDA classifies as Class 1 a GE Healthcare recall of its CareScape R860 Inspiratory Safety Guard, a breathing accessory designed for use with the Cares...
FDA clears a DBM Corp. 510(k) for its Miracu PDO Suture Threads and its use on soft tissue approximation where absorbable sutures are appropriate.
FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical ingredients.
Olympus Medical Systems and a former senior executive plead guilty to failing to file required adverse event reports involving its duodenoscopes and a...
FDA warns Indias Skylark CMC over its refusal to permit agency inspectors to enter manufacturing areas and refusal to provide requested records.