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BiCNU (carmustine for injection): FDA Alert
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Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
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Emergency Use Authorizations: RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics)
OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with whole Blood – July 31, 2015 On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa…
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication
[Posted 05/12/2016] AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not…
Summary Information for: Fluency® Plus Endovascular Stent Graft
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Summary Information for: Impella Ventricular Support Systems
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Transcript posted for April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting
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Summary Information for: TRIDYNE™ Vascular Sealant
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