Janet Woodcock on if the FDA is getting tougher on drug reviews: ‘I don’t think so’
Following a recent string of setbacks for some drug developers, acting FDA commissioner Janet Woodcock said Wednesday that she does not think the FDA is getting more stringent in its reviews of new drugs even as the agency hosts a 3-day advisory committee next week to take a closer look at several accelerated approvals.
“I don’t think so,” Woodcock said when questioned about the tougher stance at a webinar for the Alliance for a Stronger FDA. “I think that what’s happening is that science is moving into fields that typically haven’t seen advances that we’re seeing in other areas, and so I think there is some adjustment that has to be made as people deal with that.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.