FDA issues Fresenius Kabis Canton, MA outsourcing facility a Form FDA-483 over GMP deviations observed during a March inspection.
FDA clears a MedRhythms 510(k) for InTandem, a neurorehabilitation system to improve walking and ambulation in stroke patients.
FDA clears an EarliTec Diagnostics 510(k) for the second generation of its EarliPoint Evaluation for Autism Spectrum Disorder in children ages 16 to 3...
Senators Mike Lee (R-UT), Ben Ray Lujn (D-NM), Mike Braun (R-IN), and J.D. Vance (R-OH) introduce a bill to ease biosimilar interchangeability.
Federal Register notice: FDA makes available a draft guidance entitled Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CG...
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompli...
FDA approves a Gilead Sciences supplemental NDA for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairment, including those...
Federal Register notice: FDA seeks industry organizations interested in participating in the selection of nonvoting industry representatives to serve ...
