PDUFA VII Will Fund Pregnancy Postmarket Safety Update, Sentinel Upgrades, REMS Standardization

 
• By Derrick Gingery

US FDA will incorporate performance goals for reviewing REMS methodological approaches and study protocols as part of PDUFA reauthorization.

pregnant and medication
The FDA is expected to develop a consistent approach to PMRs and PMCs to assess drug and biologic effects on pregnant women during PDUFA VII. • Source: Alamy

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