FDA Trends for Accelerated Drug Approvals in Oncology Indications
The FDA has modified and increased expectations around data needed to support accelerated approvals in oncology Unlike prior trends, randomized controlled trials will be the preferred approach to support an application for accelerated approval moving forward the acceptability of single arm trials for accelerated approval will receive significant scrutiny Prolonged duration on the market for … Continued
https://www.certara.com/poster/fda-trends-for-accelerated-drug-approvals-in-oncology-indications/