FDA Review posts the Federal Register notices for the week ending 12/11/2020.
FDA grants ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treating certain patients ...
FDA posts three new guidances for device makers to use under its Safety and Performance-Based Pathway.
Federal Register notice: FDA corrects an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry due to an error...
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were n...
Federal Register notice: FDA extends the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devices.
Federal Register notice: FDA announces the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years.
FDA grants Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pain.