A Medshadow column raises concerns about FDAs stated efforts to allow some drugs to be approved based on a single pivotal trial.
House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congres...
Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the deaths of at least 1...
FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evidence for regulatory...
FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Vouche...
FDA warns Little Rock, AR-based 3D Imaging Drug Design and Development about CGMP and listing violations in its production of positron emission tomogr...
FDA extends the review of Aldeyra Therapeutics NDA resubmission for reproxalap, pushing back a regulatory decision on the investigational dry eye dise...
FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.
