Philips recalls (Class1) certain reworked DreamStation breathing devices due to some devices being assigned incorrect or duplicate serial numbers.
Federal Register notice: FDA seeks comments on an information collection extension entitled Imports and Electronic Import Entries (OMB Control Number ...
Federal Register notice: FDA adds quinacrine hydrochloride to its list of bulk drug substances (active pharmaceutical ingredients for which there is a...
Janssen Biotech and Pharmacyclics decide to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) treating patients wit...
U.S. Representative Andy Kim (D-NJ) reintroduces a bill to provide FDA with mandatory recall authority for any and all faulty or unsafe prescription a...
Florida wins a $600,000 payment to the states Medicaid program under a multistate action against cochlear implants maker Advanced Bionics and its devi...
FDA explores whether it can enter into a five-year contract with an entity that can perform non-invasive high-resolution imaging and artificial intell...
Yale University researchers suggest five steps FDA could consider to help build patient and clinician trust in drug accelerated approvals.
