FDA issues two draft guidances clarifying changes made in the recent GDUFA reauthorization.
FDA warns Diasol East about QS violations in its manufacturing of dialysis liquid and powder dialysate concentrate.
FDA denies an Apotex petition asking it to set requirements for BLAs referencing Neulasta, and doesnt comment on whether it may ultimately impose any ...
FDA issues three guidances explaining revised performance goal actions approved in the MDUFA 4 reauthorization for 510(k)s, PMAs, and de novo classifi...
The 9th Circuit Court of Appeals declines to rehear a whistleblower case involving three Gilead HIV drugs.
FDA commissioner Scott Gottlieb says the agency is making changes to make it easier for patients to gain access to experimental therapies under its ex...
Federal Register notice: An FDA advisory committee reviews a Braeburn Pharmaceuticals NDA for buprenorphine subcutaneous injection and its use for tre...
FDA releases its latest batch of Warning Letters that includes Dasan E&T Co. and Diasol East.