Regulatory Affairs Professionals Society

FDA, CMS propose new parallel review pathway for breakthrough devices

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
Becker's Hospital Review

FDA, CMS Extend Parallel Review Program

The U.S. Food and Drug Administration and CMS announced an extension on their joint Parallel Review pilot program, according to a Regulatory Focus report. Launched in October 2011, the Parallel Review ...
The National Law Review

FDA and CMS Permanently Establish Parallel Review

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
RAPS

FDA, CMS: Second Parallel Review Decision Ever for NGS Test

FDA, CMS: Second Parallel Review Decision Ever for NGS Test The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and ...
Becker's ASC

MDMA Expresses Concern Over ‘Parallel Review’ Process Proposal

The Medical Device Manufactures Association has submitted comments to CMS and the FDA concerning the jointly proposed “parallel review” process for premarket, FDA-regulated medical products, according ...