Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents:...
President Trumps chief of staff Mark Meadows summons FDA commissioner Stephen Hahn to the White House 12/1 to learn why the agency has not approved or...
FDA recognizes A2LA to assess testing laboratories for the Accreditation Scheme for Conformity Assessment pilot program.
Minerva Neurosciences says it believes it can address negative FDA comments about two roluperidone studies through published regulatory guidance and p...
FDA releases its latest batch of Warning Letters that include ForYou Inc. and Industry Lab Diagnostic Partners.
Federal Register notice: FDA issues an order permanently debarring Barry J. Cadden after a conviction in his role as an owner and director of the New ...
FDA approves a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management in patients six years and older with obesity due t...
FDA launches the Innovative Science and Technology Approaches for New Drugs pilot program for novel drug development tool developers.