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FDA releases the form FDA-483 with two observations from an inspection at the Genzyme Ireland drug manufacturing facility in Water...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at the Cohance Lifesciences drug manufacturing facility in ...[ Price : $8.95]
Sens. Rick Scott and Kirsten Gillibrand ask FDA commissioner Martin Makary to answer 11 questions about the agencys oversight of o...[ Price : $8.95]
Olympus recalls (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before 5/12 after receiving reports of device c...[ Price : $8.95]
FDA issues an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automat...[ Price : $8.95]
FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating s...[ Price : $8.95]
FDA rejects Otsuka Pharmaceutical and H. Lundbecks sNDA to expand the use of Rexulti (brexpiprazole) for treating post-traumatic s...[ Price : $8.95]
FDA takes two actions against autism by ordering a label change against acetaminophen (Tylenol) use in pregnancy approving leucovo...