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

PDUFA VII Could Increase Transparency Of REMS Release Process

 
• By Derrick Gingery

Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.

Hand turning a knob to select low risks investment. Concept of risk and reward ratio. Composite image between a hand photography and a 3D background.
The PDUFA reauthorization could shed more light on the REMS elimination process. • Source: Shutterstock

The process for eliminating a Risk Evaluation and Mitigation Strategy could become more transparent thanks to the prescription drug user fee reauthorization.

Among the final details the PDUFA VII Postmarket subgroup negotiators considered industry interest in commitment letter language describing “a process for a systemic look at REMS and eliminating REMS when...

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 Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

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.

More from Pathways & Standards

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.