Home » Industry Says PDUFA Proposal Balances Innovation and Safety
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.
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