Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Regarding Global Unique...
Federal Register notice: FDA makes available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products.
FDA releases the FDA-483 with five inspection observations issued following an inspection at Revance Therapeutics.
FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in ad...
FDA grants Varian a breakthrough device designation for its Embozene microspheres for genicular artery embolization in treating symptomatic knee osteo...
FDA posts a draft guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.
Federal Register notice: FDA withdraws three guidance documents on hand sanitizer products because consumers and healthcare personnel are no longer ex...
FDA approves a Delphinus Medical Technologies PMA for its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct to digital mammog...