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A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.[ Price : $8.95]
FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug ...[ Price : $8.95]
FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.[ Price : $8.95]
FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equin...[ Price : $8.95]
FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.[ Price : $8.95]
FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of s...[ Price : $8.95]
Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept signific...[ Price : $8.95]
FDA accepts for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat he...