Three stakeholders suggest topics for the FDA Combination Products Policy Council to address.
FDA classifies as a Class 1 recall a Medtronic voluntary field action related to its HVAD System Controllers and DC Adapters.
AMAG Pharmaceuticals files a supplemental NDA for Makena (hydroxyprogesterone caproate injection) to allow a subcutaneous auto-injector to deliver the...
FDA denies a CytoDyn request for an orphan drug designation for PRO 140 because the therapy appears to have the potential to treat more than just the ...
Editor Jim Dickinson analyzes a remarkable case of apparent and highly questionable FDA collusion with a medical device companys marketing campaign ag...
FDA schedules a 5/24 Oncologic Drugs Advisory Committee meeting to review a Puma Biotechnology NDA for neratinib, an investigational therapy for the e...
Rigel Pharmaceuticals files an NDA for fostamatinib in patients with chronic and persistent immune thrombocytopenia.
FDA releases a Form-483 from a 2/7-17 inspection at Abbotts St. Jude Medical manufacturing facility in Sylmar, CA, that found Quality System Regulatio...