1. Pink Sheet

21st Century Cures Bill Could Create More Prescriptive Rx Approval Standards For FDA

 
• By Sarah Karlin-Smith

Simplified and speedier drug approval process is focus for Reps. Upton and DeGette’s upcoming legislation – but getting there may mean more congressional micromanaging over FDA’s drug approval standards.

Reps. Fred Upton and Diana DeGette have offered a first peak at the concepts the pharma industry can expect to see in draft biomedical reform legislation known as the 21st Century Cures Initiative.

The legislation, expected to be released in January, will “streamline the approval of drugs,” Upton and DeGette said

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