FDA accepts for review an OptiNose NDA for OPN-375 and its use in treating nasal polyposis in adults.
House Energy and Commerce Committee Democrats send a letter to president Trump asking for clarification on FDAs hiring authority in the wake of a hiri...
A Vox article challenges the notion, reportedly being entertained by the Trump Administration, that FDA can adapt Silicon Valley processes to speed dr...
Attorney Suzan Onel says the 21st Century Cures Act provides some clarity on types of software that FDA considers to be exempt from the medical device...
FDA warns Canadas Ropack, Inc., about multiple quality system violations in its manufacturing of artificial saliva.
President Donald Trump meets with pharmaceutical company CEOs and urges drug pricing relief in exchange for less FDA regulation, faster approvals and ...
Public Citizen president Robert Weissman protests a new Trump administration executive order requiring agencies to repeal two regulations for every on...
Four stakeholders suggest general and specific changes to an FDA draft guidance on the format and content of physiologically based pharmacokinetic ana...