Gottlieb Provides Update One Year After the Cures Act

The FDA expects to see more drugs provide more data showing survival benefits earlier in product development, Commissioner Scott Gottlieb told lawmakers at a one-year follow-up hearing on the 21st Century Cures Act.

This would allow sponsors to take broader advantage of the agency’s expedited programs.

Gottlieb also provided an update on the FDA’s regulatory science work in continuous manufacturing, and efforts to better define intermediate and surrogate endpoints.