accelerated approval

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accelerated approval2016-12-12T03:48:22+00:00

accelerated approval 

EVIDENCE-BASED MEDICINE, THERAPEUTICS

A self-explanatory term for a regulatory mechanism developed by the FDA (USA) to make new drug products available for serious or life threatening diseases when they appear to provide a benefit over available therapy–or where there is no effective treatment.

Accelerated approval is granted on the condition that the manufacturer continues testing to confirm the drug’s therapeutic benefit, in absence of which, the FDA can withdraw the product from the market more easily than usual. 

Reference http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm

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