Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) awards the breakthrough therapy designation to expedite development and review of therapeutics intended to treat serious conditions when preliminary clinical evidence demonstrates potential substantial improvement over existing therapies on clinically significant end points. Under the 21st Century Cures Act of 2016, the FDA is required to publish and routinely update a list of surrogate markers to provide industry sponsors with indication-specific information about end points that were or may be considered for approval. Therapeutics that are granted breakthrough therapy designation can receive accelerated or traditional approval; however, little is known about those approved through the latter pathway, where postmarketing confirm

SUBMITTER: Mooghali M 

PROVIDER: S-EPMC11350476 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature