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.