FDA warns Indias Glenmark Pharmaceuticals about a CGMP violation in its production of finished pharmaceuticals.
Three stakeholders suggest changes to an FDA draft guidance on the inactive ingredient database.
FDA makes available a transcript of a 9/10 Patient Engagement Advisory Committee that recommended the agency develop standards for device companies to...
FDA releases its latest batch of Warning Letters that includes Glenmark Pharmaceuticals, Torrent Pharmaceuticals, Coral Pharmaceuticals and Denterpris...
FDA approves an Akorn ANDA for betamethasone dipropionate lotion USP, 0.05%, a corticosteroid indicated for relieving inflammatory and pruritic manife...
FDA warns Denterprise International about Quality System and Radiological Health violations in its work as a specification developer, manufacturer of ...
FDA says it does not have scientific evidence on which to base a recommendation to continue using or discontinue Zantac due to the presence of NDMA im...
Sanofi researchers analyze FDA use of patient experience data in 2018 new molecular entity approvals to establish a baseline for further study.