BioCentury
ARTICLE | Politics & Policy

Gottlieb highlights changes to improve expanded access program

November 9, 2018 12:13 AM UTC

FDA Commissioner Scott Gottlieb on Thursday highlighted recent and upcoming changes to the agency's expanded access program (EAP) that the agency believes will improve access for patients and remove ambiguity for companies.

Gottlieb said the agency has worked over the past year to expand and update the program by streamlining the paperwork and simplifying internal review board (IRB) review. If a single patient requests expanded access, now only one IRB member is needed to approve the request, rather than the entire board. ...