FDA grants Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) Alzheimers Disease...
FDA seeks feedback on a discussion paper entitled Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.
Federal Register notice: FDA withdraws approval of 35 NDAs at the request of their sponsors.
FDA adopts an international guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.
Federal Register notice: FDA makes available a final guidance entitled Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria.
Federal Register notice: FDA determines that Norflex (orphenadrine citrate) injection and extended-release tablets were not withdrawn from sale for re...
FDA releases the form FDA-483 with 10 observations from an inspection at the Telangana, India-based Aurobindo Pharma Unit IX active pharmaceutical ing...
The FDA Digital Health Center of Excellence publishes a 2022 report on non-device software functions.
