Federal Register notice: FDA announces a 4/30 public workshop entitled Orthopedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Device...
Federal Register notice: FDA amends a notice about a 3/1 Neurological Devices Panel of the Medical Devices Advisory Committee meeting to reflect a cha...
Federal Register notice: CDER proposes to refuse approval of a Pharmaceutical Manufacturing Research Services NDA for oxycodone hydrochloride immediat...
FDA releases its latest batch of Warning Letters that includes Bayer AG, Cosmecca Korea Co., Curasan AG, Guangzhou Baiyunshan Pharmaceutical Holdings ...
Two stakeholders say clarifications are needed in an FDA draft guidance on clinical decision support software.
Three stakeholders say an FDA draft guidance on drug development for pediatric rare diseases relies too heavily on Gaucher disease as a model.
Sen. Claire McCaskill releases a report demonstrating that opioid manufacturers have contributed heavily to third-party associations that support opio...
Public Citizen send FDA study results it says confirm that olmesartan is associated with an increased risk of sprue-like enteropathy.