Countdown to Cures
From the article:
[...] According to Rachel Sachs, an academic fellow at the Petrie-Flom Center at Harvard Law School who has been following the Act with interest, 21st Century Cures has the potential to completely overhaul the existing system for bringing new treatments to the public. “The titles of the three main parts of the Act say it all. Often, a statute will address a single one of these goals. For instance, the ‘Doc Fix’ legislation passed in April 2015 addressed the Medicare delivery system, and every five years a new version of the Prescription Drug User Fee Act presents an opportunity to alter the FDA’s review process. An opportunity to address all three important areas – discovery, development and delivery – at once is potentially very exciting.” [...]
Read the Full Article (free registration required)
Tags
fda health law policy innovation pharmaceuticals rachel sachs regulation