Federal Register notice: FDA announces a 10/22 public advisory committee meeting of its Science Board. that will hear a response from CVM on recommend...
Pharm D Solutions recalls all sterile compounded drug products within expiry due to concerns that practices at the pharmacy have the potential to pose...
Federal Register proposed rule: FDA proposes to amend requirements for medical device premarket submissions to remove paper and multiple copies and re...
FDA approves a Staar Surgical PMA supplement for the Visian Toric Implantable Collamer Lens for the correction of myopia with astigmatism.
FDA says a new, unexpected impurity has been found in some lots of recalled drug products containing the active ingredient valsartan.
FDA commissioner Scott Gottlieb outlines a new regulatory framework he has suggested to Congress for diagnostic tests.
FDA releases the FDA-483 with nine observations from an inspection at Japans Yuki Gosei Kogyo API manufacturer.
FDA publishes a draft guidance and a finalized guidance on voluntary consensus standards for medical devices.