Federal Register notice: FDA makes available a draft guidance entitled Bioavailability Studies Submitted in NDAs or INDs General Considerations.
Federal Register notice: FDA reopens the comment period for an 11/20/2018 notice entitled Prescription Drug-Use-Related Software; Establishment of a P...
FDA issues an FDA-483 with two observations from an inspection at Indias Aurobindo Pharma Unit 4.
FDA joins CDC and CMS in a partnership to advance development and deployment of diagnostic tests during public health emergencies.
FDA approves a Romeg Therapeutics 505(b)(2) NDA for Gloperba (colchicine) Oral solution, 0.6 mg/5 mL for prophylaxis of gout flares in adults.
The 3rd Circuit Appeals Court rejects the rationale in an FTC suit against Shire for allegedly anti-competitive conduct that the company stopped five ...
FDA issues an FDA-483 with four observations from an inspection at the Dr. Reddys facility in Andhra, Pradesh, India.
FDA clears a Sensus Healthcare 510(k) for the Sculptura radiation oncology system, a single radiation treatment used during cancer surgery.