Biotech Leaders Concerned About FDA Uncertainty
Biotech leaders are expressing concerns that uncertainty at the FDA is threatening drug development.
The recent rejections of Replimune and Capricor therapies by the FDA have highlighted the issue of instability at the agency.
“It is going to kill drug development if you don’t have consistency and transparency,” said Replimune CEO Sushil Patel. “It’s really going to make it very difficult for us to bring innovative treatments to patients faster.”
CEO's of Replimune and Capricor discussed the importance of a stable FDA at the STAT Summit.
Author's summary: FDA uncertainty threatens biotech innovation.