The Office of the National Coordinator provides an emergency telephone number for FDA to be used in healthcare facilities experience a ransomware cybe...
FDA clears a Varian Medical Systems 510(k) for its Halcyon system for cancer treatment.
FDA says a Dr. Reddys plant fails to make appropriate laboratory determinations before releasing a drug.
Federal Register notice: FDA seeks comments on a statement of work for an assessment of the Program for Enhanced Review Transparency and Communication...
Former FDA associate commissioner Joshua Sharfstein says a commitment to expanded data collection is needed to help avoid controversies over FDA regul...
FDA publishes the FDA-483 with five observations from a Lupin Limited inspection in India.
FDA grants Marinus Pharmaceuticals an orphan drug designation for ganaxolone for treating CDKL5 Disorder.
FDA allows the marketing of Beckman Coulters ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to a...