[ Price : $8.95]
FDA publishes three Federal Register notices on device classifications related to de novo requests.[ Price : $8.95]
FDA updates the CDRH Recognized Consensus Standards database, adding List 59.[ Price : $8.95]
FDA modifies the mifepristone REMS to remove the in-person dispensing requirement and permit dispensing by certified pharmacies.[ Price : $8.95]
In addition to a $226 million boost in FDA spending levels, the year-end omnibus spending bill also includes notable agency reform...[ Price : $8.95]
FDA says Accord Healthcare recalled one lot of daptomycin for injection due to a labeling mix-up.[ Price : $8.95]
FDA approves a resubmitted Acer Therapeutics NDA for its Olpruva to treat some patients with urea cycle disorders.[ Price : $8.95]
FDA warns The Woodlands, TX-based RoyalVibe Health about manufacturing, marketing, and distributing unapproved medical devices tha...[ Price : $8.95]
FDA warns Sagent Pharmaceuticals about issues found in an inspection at its Plattsburg, NY-based sterile drug products manufacturi...