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FDA seeks to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a b...[ Price : $8.95]
A Quality Magazine article explains what FDA investigators have focused on in their initial Quality Management System Regulation i...[ Price : $8.95]
FDA releases the form FDA-483 issued after a 2024 inspection at the Excelvision drug manufacturing facility in Annonay, Ardche, Fr...[ Price : $8.95]
FDA grants a fast track designation to Scancells advanced melanoma investigational drug iSCB1+.[ Price : $8.95]
FDA commissioner Marty Makary says the agency is still weighing candidates to lead CBER as controversial director Vinay Prasad pre...[ Price : $8.95]
Rocket Pharmaceuticals sells an FDA rare pediatric disease priority review voucher for $180 million to support its gene therapy pi...[ Price : $8.95]
FDA plans to unveil a significant shift in how clinical trials are conducted and regulated, announcing major steps to implement re...[ Price : $8.95]
Galaxy Therapeutics has submitted the final module of a PMA for its SEAL device, a treatment designed for patients with wide-neck ...