CDER says its statisticians are working on adaptive clinical trial designs to make clinical evaluation of new drug treatments more efficient and infor...
A just-posted Form 483 includes nine observations from an inspection at Temple, TX-based QuVa Pharma.
Federal Register notice: FDA submits to OMB a revised information collection on Tropical Disease Priority Review Vouchers.
Federal Register notice: FDA publishes a list of nine information collections that have been approved by OMB.
Brainlab recalls its Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that may prevent t...
FDA grants FibroGen an orphan drug designation for the companys anti-cognitive tissue growth factor antibody, pamrevlumab, for treating patients with ...
FDA approves an Intact Vascular PMA for the Tack Endovascular System, a dissection repair device implanted post-angioplasty in patients with periphera...
FDA clears Gelesis Plenity (Gelesis100) as an aid in weight management in adults with a body mass index of 25 to 40 kg/m when used in conjunction with...