Definition: FDA Approval
The Food and Drug Administration - FDA is US Department of Health and Human Services authority responsible for regulating and supervising the safety of foods, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
FDA does not regulate non safety related approvals - the FDA regulates prescription drugs, testing, manufacturing, labeling, advertising, marketing, efficacy and safety, however FDA regulation of cosmetics is focused primarily on the safety aspects of labeling.
The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency however FDA authority and regulation is recognised as the pre-eminent authority of its type in most countries of the western world.
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05/21/2012 09:07 PM
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TEXT-S&P rates Jazz PharmaceuticalsReutersThe key asset obtained with the EUSA acquisition is Erwinase/Erwinaze, which received FDA approval late last year as an adjunct to chemotherapy for patients with acute lymphoblastic leukemia (ALL). Current treatment regimens include bacterial-derived ... |
05/21/2012 07:41 PM
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05/21/2012 07:27 PM
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05/21/2012 04:42 PM
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05/21/2012 03:54 PM
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Actavis wins FDA approval for Ropinirole extended-release tabletsPharmaceutical Business ReviewActavis Group, a generic pharmaceuticals company, has gained FDA approval for Ropinirole extended-release tablets, 2mg, 4mg, 6mg, 8mg and 12mg. The company has started distribution of the generic version of GlaxoSmithKline's Requip XL. |
05/21/2012 10:26 AM
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