FDA commissioner Scott Gottlieb announces a sweeping reorganization of CDRH, saying it is introducing a Medical Device Safety Action Plan focusing on ...
FDA warns Hong Kongs Luen Wah Medicine about CGMP violations in its production of finished pharmaceuticals.
FDA warns SynCardia Systems about Medical Device Reporting violations associated with production of its total artificial heart system.
Four senators introduce bipartisan legislation to clarify breakthrough and accelerated approvals for novel non-opioid or non-addictive pain medication...
FDA releases its latest batch of Warning Letters that includes Hanbul Cosmetics Co., Luen Wah (HK) Medicine and SynCardia Systems.
FDA approves an Ultragenyx Pharmaceutical NDA for Crysvita (burosumab), the first drug approved to treat adults and children ages one year and older w...
FDA approves an Abbott firmware update for its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to bat...
Federal Register notice: FDA makes available a guidance on Highly Concentrated Caffeine in Dietary Supplements.