FDA releases an FDA-483 with five observations from its inspection at a Dr. Reddys API manufacturing facility in India.
FDA approves an expanded indication for Novartis Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients aged one year o...
CBER publishes a list of 12 guidances it intends to release this calendar year.
FDA says that Becton Dickinson tests have demonstrated that Magellan LeadCare blood tests have a significant chance of false results when used with ve...
The House and Senate pass a fiscal year 2018 omnibus budget bill that will increase FDAs budget authority by $41 million (1.5%) over FY 2017.
FDA clears an Orthofix International 510(k) for its new internal fixation system, the G-Beam Fusion Beaming System, intended for use in treating Charc...
FDA says there have been 414 medical device adverse event reports on breast implant-associated anaplastic large cell lymphoma.