FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug that is also an unl...
In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency actions that have draw...
FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report from last week saying ...
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FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.
President Trump appoints Yale epidemiologist Harvey Risch to chair the Presidents Cancer Panel, a move that is raising alarm among cancer researchers ...
FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.
