[Solved]: – Process in which drugs for serious conditions…

– Process in which drugs for serious conditions that fill an unmet medical need are approved early based on a surrogate endpoint. – Process in which the FDA acts on an application within 6 months compared to 6 months under standard review. – Process designed to expedite the development and review of drugs that are intended to treat a serious condition and may offer substantial improvement over available therapy on a clinically significant endpoint(s). – Process which grants exclusive marketing right for 7 years for a rare disease indication, a tax credit for cost associated with the clinical testing and grants for clinical trials. – Process designed to get important new drug to patient earlier, facilitating the development and review of drug that treat serious condition and fill an unmet medical need.