FDA acting commissioner Ned Sharpless says the White House and HHS want him to continue the leadership path set by former commissioner Scott Gottlieb.
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.
Federal Register notice: FDA submits to OMB an information collection extension for Oversight of Clinical Investigations: A Risk-Based Approach to Mon...
FDA accepts a Novartis BLA for brolucizumab (RTH258) for treating wet age-related macular degeneration.
Brainlab recalls its Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that may prevent t...