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.
FDA extends the review of a Flexion Therapeutics supplemental NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension) that s...
A new JAMA study finds minimal effects from FDAs recent policies to expand approvals for generic drugs at risk for price spikes and shortages.