1. Pink Sheet

CMS Needs Regulatory Science, Chief Scientist To Coordinate With US FDA, Former Official Says

 
• By Derrick Gingery

Sean Tunis embraces a bigger decision-making role for CMS in product access, while FDA Commissioner nominee Robert Califf also calls for smoother FDA-CMS hand-offs, and CBER Director Peter Marks wants a quicker FDA-CDC approval and deployment process.

two lines converge
A CMS Office of Chief Scientist and Office of Regulatory Science could help it coordinate actions with the FDA, Sean Tunis argued. • Source: Alamy

The US Centers for Medicare and Medicaid Services may need a regulatory science component to improve its relationship with the Food and Drug Administration and harmonize approval and coverage policies.

Sean Tunis, a principal at Rubix Health and former CMS chief medical officer, said during the recent Innovations in Regulatory...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Product Reviews

More from Pink Sheet

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.