Public Comment
Submitted on: February 4, 2025
Submitted to: Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
The MRCT Center submitted public comments in response to FDA’s draft guidance on the accelerated approval program, suggesting areas needing further clarification such as the identification and validation of surrogate endpoints, the rigor and timeliness of confirmatory trials, expansion of public disclosures for regulatory actions, increased transparency regarding decision-making and withdrawal, and global considerations in the absence of international harmonization of these regulations.