RE:RE:RE:RE:How does Accelerated Approval work September 17, 2024 -
21 USC 356: Expedited approval of drugs for serious or life-threatening diseases or conditionsText contains those laws in effect on September 17, 2024 From Title 21-FOOD AND DRUGSCHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER V-DRUGS AND DEVICESPart A-Drugs and Devices
Accelerated approval of a drug for a serious or life-threatening disease or condition, including a fast track product
(1) In general
(A) Accelerated approval
The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 355(c) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. The approval described in the preceding sentence is referred to in this section as "accelerated approval".
(B) Evidence
The evidence to support that an endpoint is reasonably likely to predict clinical benefit under subparagraph (A) may include epidemiological, pathophysiological, therapeutic, pharmacologic, or other evidence developed using biomarkers, for example, or other scientific methods or tools.
https://uscode.house.gov/view.xhtml?req=(title:21%20section:356%20edition:prelim)