Federal Register notice: FDA announces a 9/13 public workshop entitled Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnosti...
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.