FDA/CMS Parallel Review Not Needed For Biopharma Products – PhRMA And BIO
The two major trade associations representing drug and biological manufacturers are telling FDA and CMS that their proposed parallel review process is neither appropriate nor necessary for biopharma products.
You may also be interested in...
Strict conflict-of-interest restrictions will make it very challenging to get people confirmed to serve on the Independent Payment Advisory Board established under the 2010 health reform law, according to a top health care advisor to Mitt Romney. IPAB was addressed in the Oct. 3 presidential debate.
At its next meeting May 16, the Medicare Evidence Development and Coverage Advisory Committee will hear from former CMS and FDA head Mark McClellan, who has supported the notion of linking Medicare’s coverage with evidence development tool with accelerated drug approvals.
CMS Guidance On Desired Data Might Meet The Goals Of Parallel Review More Reasonably, Former Official Gottlieb Suggests
AEI's Scott Gottlieb, a former official at FDA and CMS, offers his insights into the proposed parallel review program during Avalere conference.