Another Chance to Make Priority Review Vouchers Work
One of the “innovation” pieces of the FDA Safety & Innovation Act is a priority review voucher program for drugs to treat pediatric rare diseases. The new PRV is designed to avoid some of the glitches that have complicated the value of the program in tropical diseases—but it can’t avoid the core problem inherent in trying to capture the value of a priority review by legislative fiat.
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
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The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
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The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
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Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
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