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FDA, CMS Working To Smooth ‘Baton Handoff’ From New Drug Approval To Reimbursement

 
• By Sue Sutter

FDA commissioner Robert Califf wants to develop a postapproval evidence generation system through ongoing collaboration with CMS. Public health experts say efforts by FDA and CMS to work more closely could result in greater clarity on trial designs early in development programs.

Passing the baton
The handoff from drug approval to reimbursement should be smoother, FDA's Califf says. • Source: Shutterstock

The US Food and Drug Administration and Centers for Medicare and Medicaid Services are working together to try to smooth what FDA commissioner Robert Califf calls the “baton handoff” from new drug approval to reimbursement.

Although few specifics about the collaborative effort have been publicly disclosed, the initiative appears aimed at avoiding a repeat of...

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US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
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More from Pink Sheet

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

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Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By Joseph Haas

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.