FDA updates the CDRH Recognized Consensus Standards database, adding List 59.
FDA modifies the mifepristone REMS to remove the in-person dispensing requirement and permit dispensing by certified pharmacies.
In addition to a $226 million boost in FDA spending levels, the year-end omnibus spending bill also includes notable agency reforms that were once par...
FDA says Accord Healthcare recalled one lot of daptomycin for injection due to a labeling mix-up.
FDA approves a resubmitted Acer Therapeutics NDA for its Olpruva to treat some patients with urea cycle disorders.
FDA warns The Woodlands, TX-based RoyalVibe Health about manufacturing, marketing, and distributing unapproved medical devices that are misbranded and...
FDA warns Sagent Pharmaceuticals about issues found in an inspection at its Plattsburg, NY-based sterile drug products manufacturing facility.
FDA says it is delaying the PDUFA action date for Phathoms vonoprazan to treat erosive esophagitis while the company submits additional stability data...
