Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide recommendations on ANDA bioequ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Center for Devices and Radiological Health Appeals Process...
Federal Register notice: FDA classifies the electromechanical tear stimulator into medical device Class 2.
Federal Register notice: FDA classifies the integrated continuous glucose monitoring system into medical device Class 2.
Federal Register notice: FDA classifies the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access into medical device...
FDA extends a clinical hold on BioMarin Pharmaceuticals PHEARLESS Phase 1/2 study of BMN 307, an AAV5-human phenylalanine hydroxylase gene therapy bei...
The Alliance for a Stronger FDA says that commissioner Robert Califfs first priorities should focus on renewed attention to data and technology modern...
Pew Charitable Trusts health care products director Liz Richardson says CDRH should increase transparency by requiring more and better information on ...