Two stakeholders say clarifications are needed in an FDA draft guidance on clinical decision support software.
Three stakeholders say an FDA draft guidance on drug development for pediatric rare diseases relies too heavily on Gaucher disease as a model.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.
FDA commissioner Scott Gottlieb praises the administrations budget request for an additional $400 million to promote innovation and competition.
FDA warns Cosmecca Korea about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA stands to gain a $663 million (13%) budget boost in President Trumps just-released fiscal year 2019 budget proposal.
FDA adds new information to the labeling of warfarin international normalized ratio test meters based on adverse events.