FDA clears a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass.
Researchers say pivotal clinical trials often are not the main reason for the high cost of drug development.
FDA warns Indias Wilson Medicine Co. about CGMP violations in the production of finished drugs.
FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of radiopharmaceuticals.
Federal Register notice: FDA announces an opportunity for public comment on an information collection extension entitled Generic Drug User Fee Cover S...
CDER Office of Process and Facilities branch chief Ying Zhang outlines common issues and deficiencies cited during pre‐approval drug inspections
Washington Legal Foundation urges the Supreme Court to reject a 3rd Circuit Court of Appeals ruling that a preemption case should be decided by a jury...
CDER Division of Biometrics IV director Dionne Price outlines ways in which FDA will promote use of complex innovative trial designs.