Attorney Michelle Yeary says the 3rd Circuit Court of Appeals has ruled that multi-component medical devices should be evaluated for preemption compon...
FDA approves an Orthofix International PMA for its next-generation Physio Stim bone growth stimulator.
Five stakeholders recommend changes to an FDA draft guidance on good ANDA submissions.
Sagent Pharmaceuticals recalls 10 lots of methylprednisolone sodium succinate for injection (40mg, 125mg and 1g) due to the discovery of high out-of-s...
Dermiras investigational treatment olumacostat glasaretil fails to meet its co-primary endpoints in two Phase 3 pivotal trials in patients ages nine y...
FDA warns Hong Kongs Nan San Pharmaceutical Company about CGMP and other violations in its production of finished pharmaceuticals.
FDA releases its latest batch of Warning Letters that includes Nan San (HK) Pharmaceutical Factory and Zhejiang Ludao Technology Co.
FDA expands the approval of St. Jude Medicals Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff to include a 15-mm valve size t...