FDA accepts for review an Acer Therapeutics NDA resubmission for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea ...
Medtronics Covidien unit recalls (Class 1) its Palindrome and Mahurkar catheters due to a catheter hub defect that presents a potential leaking condit...
A bill that would establish a task force between the U.S. Patent and Trademark Office and FDA to improve communication and coordination in implementin...
FDA approves a Lenstec PMA for its SBL-3 IOL (Segmented Bifocal Lens), a next-generation asymmetric multifocal refractive intraocular lens.
Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative S...
Federal Register notice FDA announces the fiscal year 2023 rates for the establishment and reinspection fees related to entities that compound human d...
Federal Register notice: FDA makes available a draft guidance entitled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers Patient Labeling Recommen...
Federal Register notice: FDA sets fee rates and payment procedures for fiscal year 2023 for animal drug user fees.
