1. Pink Sheet
  2. >>Pathways & Standards
  3. >>User Fees

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

The upcoming prescription drug user fee cycle should improve sponsors’ understanding of Risk Evaluation and Mitigation Strategy requirements, as well as improve their assessment planning.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from User Fees

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

More from Pathways & Standards

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
• By Eliza Slawther

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.