Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2018 animal drug user fees.
Federal Register notice: FDA seeks comments on a new information collection for De Novo Classification Process (Evaluation of Automatic Class 3 Design...
FDA publishes a guidance to help sponsors in clinical development of new antibacterial drugs.
Teva asks FDA to revise a draft guidance on pre-submission facility correspondence associated with priority ANDA submissions to remove information gat...
FDA releases its latest batch of Warning Letters that includes Absonutrix and Medical Center Pharmacy.
FDA clears a Xavant Technology 510(k) for the Stimpod NMS460, a hybrid-pulsed radio frequency waveform neuromodulation device for relieving and managi...
Sen. Richard Blumenthal (D-CT) introduces a bill (S 1656) to amend the federal Food, Drug, and Cosmetic Act to provide cybersecurity protections for m...
Four stakeholder groups praise FDA efforts in publishing the Biosimilar User Fee Agreement Statement of Work before the 10/1 anticipated agreement app...