Skye Bioscience Inc (SKYE)

[MasterBlastr]

Senate Clears Bill to Ease FDA Drug and Device Approvals

Measure includes money for NIH, cancer moonshot, precision medicine initiative.

12-7-16 9:25 PM EST

By Thomas M. Burton

President Obama is expected to sign the 21st Century Cures bill

Passage of legislation aimed at speeding up Food and Drug Administration 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 in getting 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.

The bill's mechanisms allow the FDA to use shorter and simpler studies more widely. Under the measure, certain new antibiotics could see shorter trials, and a fairly wide range of drugs could get additional approvals for new uses based on relatively low amounts of evidence, such as data summaries and data from company registries.

An expanded version of this report appears at WSJ.com (http://www.wsj.com/articles/senate-clears-bill-to-ease-fda-drug-and-device-approvals-1481139236?mod=mktw).

news.morningstar.com/all/market-watch/TDJNMW20161207584/senate-passes-bill-to-speed-up-fda-drug-approvals.aspx