Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2018.
Federal Register notice: FDA announces rates for biosimilar user fees for fiscal year 2018.
FDA grants accelerated approval to Bayer Healthcare Pharmaceuticals Aliqopa (copanlisib) for treating adults with relapsed follicular lymphoma who hav...
FDA issues a draft guidance on its current thoughts on how animal transplant models can be used to evaluate organ preservation technologies.
Hyman, Phelps & McNamara attorneys say that since 2015 FDA has been demonstrating flexibility leading to increased fast track approvals.
Federal Register notice: FDA makes available a draft guidance entitled Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendatio...
Medtronic recalls several lots of infusion sets used with all models of Medtronic insulin pumps due to a defective vent membrane.
The FDA Office of Criminal Investigations says three Florida residents have been charged in connection with importing, manufacturing, and distributing...