1. Pink Sheet

PDUFA VII Talks Begin With Similar Goals For Industry, US FDA

 
• By Derrick Gingery

Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.

US FDA entrance sign
PDUFA VII talks began 15 September and likely will last several months. • Source: File photo

Industry and US Food and Drug Administration officials opened prescription drug user fee reauthorization negotiations with similar priority lists.

Talks began with a five-hour virtual meeting on 15 September where each side offered their discussion topics for program adjustments

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