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FDA reviewers plan to ask an advisory committee this week about its concerns with ocular toxicity seen in trial data submitted by ...[ Price : $8.95]
FDA warns Dr. Mark Savant and his San Francisco Research Institute about bioresearch monitoring violations in his conduct of a cli...[ Price : $8.95]
FDA approves a Biocon Biologics BLA for its rapid-acting interchangeable biosimilar insulin product Kirsty (insulin aspart-xjhz).[ Price : $8.95]
FDA releases the form FDA-483 containing eight observations from an inspection at the Sun Pharmaceutical drug manufacturing facili...[ Price : $8.95]
Researchers, including CBER director Vinay Prasad, call for incentivized or mandated head-to-head randomized controlled trials of ...[ Price : $8.95]
BD and subsidiary CareFusion issue an Urgent Medical Device Recall (Correction) letter related to performance issues involving the...[ Price : $8.95]
CBER director Vinay Prasad again overrides career staff to limit a Covid vaccines use, according to a just-posted decisional memo....[ Price : $8.95]
HHS notifies over 3,000 FDA employees that their employment has been officially terminated effective 7/14.