Posted by Michael Wonder on 08 Dec 2016
US Senate clears bill to ease FDA drug and device approvals
7 December 2016 - Measure includes money for NIH, cancer moonshot, precision medicine initiative.
Passage of legislation aimed at speeding up FDA approvals, combined with an incoming president who has pledged to “cut red tape” at the agency, is expected to usher in a new, more industry-friendly era of drug and device regulation.
The Senate on Wednesday cleared the measure known as the 21st Century Cures bill, which lays out in detail speedier and more pro-industry methods for the FDA to approve new drugs and medical devices. Its supporters, such as PhRMA, the drug-industry association, and AdvaMed, representing device makers, praise it as a way to bring about more innovation and get treatments to patients faster.
Republicans have been pushing for the changes for the past few years, arguing that the FDA takes too long to study scientific evidence and sometimes wrongly insists on large, multiyear clinical studies that delay important treatments to patients.
