Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls

untitled 2014-04-04

Summary:

By Michael Young In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and … Continue reading

Link:

http://blogs.law.harvard.edu/billofhealth/2014/04/03/expedited-fda-approval-for-breakthrough-therapies-promises-and-pitfalls/

From feeds:

Blogs.law Aggregation Hub » untitled

Tags:

biotechnology empirical fda health law policy intellectual property medical quality medical safety michael j. young pharmaceuticals resource allocation scientific evidence

Authors:

michaelyoung

Date tagged:

04/04/2014, 02:10

Date published:

04/03/2014, 22:07