FDA clears a Varian 510(k) for a new version of its Velocity cancer imaging software which includes Rapidsphere, a module for Y90 Selective Internal R...
FDA clears a Johnson & Johnson Vision Care 510(k) for the first contact lens to incorporate an additive that automatically darkens the lens when expos...
Federal Register notice: FDA submits for OMB approval an information collection extension for Class 2 Special Controls Guidance Document: Labeling for...
FDA denies an Insys Therapeutics petition asking for restrictions on ANDAs for a generic form of its Syndros.
FDA publishes an International Conference on Harmonization addendum to a 2000 guidance on clinical investigation of medicinal products in the pediatri...
FDA says the Custom Ultrasonics System 83 Plus automated endoscope reprocessor has been validated to effectively disinfect and Olympus and a Pentax du...
FDA releases an FDA-483 with three observations from an inspection at Indias Alembic Pharmaceuticals.
Federal Register notice: FDA makes available a draft guidance on Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs....