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Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of complaints about the safet...[ Price : $8.95]
Federal Register notice: FDA makes available a replacement final guidance entitled Investigational Covid-19 Convalescent Plasma.[ Price : $8.95]
Federal Register notice: FDA withdraws a May-issued final guidance entitled Investigational COVID19 Convalescent Plasma because th...[ Price : $8.95]
Former FDA commissioner Scott Gottlieb criticizes a recent move by HHS to redirect its authority to prevent FDA and other health a...[ Price : $8.95]
FDA approves a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications.[ Price : $8.95]
Becton, Dickinson says four previously announced recalls of its BD Alaris System have been classified as Class 1 for three events ...[ Price : $8.95]
CDRH updates its public Manufacturer and User Facility Device Experience database to improve transparency and analysis of medical ...[ Price : $8.95]
FDA Review posts the Federal Register notice for the week ending 9/18/2020.