Industry Says PDUFA Proposal Balances Innovation and Safety

The FDA’s goals for the next version of PDUFA strike a balance between fostering innovation via real-world data usage while still preserving safety standards, PhRMA and BIO officials concluded after reviewing the agency’s proposal.

Under a draft of the FDA’s benchmark goals for the next five-year cycle of PDUFA, the agency is taking a walk-before-you-run approach to study design, explained PhRMA Vice President Jeff Francer during a briefing on the issue. The performance goals were issued by the agency.