A Harvard Medical School study finds it may be possible to use nonrandomized real-world data to provide supportive evidence in establishing an sNDA in...
The CDER Office of Prescription Drug Promotion warns Amherst and Magna about false and misleading statements on a Web page and exhibit panels for Zolp...
FDA clears a Medicrea Group 510(k) for its IB3D range of 3D-printed Titanium interbody devices with its AdapTEK in-house additive manufacturing platfo...
Janssen Biotech files a supplemental BLA for Darzalex (daratumumab) and its expanded use in combination with bortezomib, melphalan and prednisone for ...
FDA approves a RxSight adjustable intraocular lens for use following cataract surgery.
FDA releases its latest batch of Warning Letters that includes Hubei Danjiangkou Danao Pharmaceutical and Vita-Pure.
FDA commissioner Scott Gottlieb says the agency has issued a new guidance and taken other steps to help sponsors test and seek approval for generic ab...
Federal Register notice: FDA seeks comments on an information collection extension for 513(g) Request for Information OMB Control Number 0910-0705.