US FDA's New Drug Assessors More Experienced With Rare Disease Issues
Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.
You may also be interested in...
A plurality of the questions from the Senate HELP Committee at Stephen Hahn's confirmation hearing to head the US FDA focused on drug development issues, despite the time lawmakers spent discussing the agency's regulation of e-cigarettes.
A COE modeled after the Oncology Center of Excellence, which stakeholders had proposed, is not in the works, but rather a more virtual structure.
Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.