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30 May 2016

What is USFDA Accelerated Approval Program of new molecular entities?

The FDA devised the Accelerated Approval Program to allow earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.

Two important criteria to get drugs into accelerated approval program are

  • Drug should be treated / indicated for serious conditions
  • Drugs should be used for unmet medical need.

What is surrogate endpoint?

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

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