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

Predicting The User Fee Reauthorization Schedule

 
• By Derrick Gingery and Nielsen Hobbs

PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.

User Fee Reauthorization Preview 2020
Industry and US FDA officials likely will meet for months to hammer out the agreements needed to reauthorize the three user fee programs. • Source: Pink Sheet illustration

The US Food and Drug Administration hasn't announced the initial public meetings to discuss the structure of the next iterations of the user fee programs, but a look at the last two cycles suggests that they could be scheduled for late spring or mid-summer.

More From The Pink Sheet User Fee Reauthorization Preview

PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be...

Welcome to Pink Sheet

Create an account to read this article

Already a subscriber?

More from User Fees

PDUFA VIII: FDA Pilot Programs, Workforce Challenges Could Shape Renewal Debate

 
• By Sue Sutter

The next iteration of the user fee program could depart from longstanding agency commitments to issue formal guidance given the Trump Administration’s deregulatory philosophy, policy experts said.

Tidmarsh Creates More Instability And Uncertainty For US FDA, Industry

 
• By Sarah Karlin-Smith

The issues surrounding the FDA's Center for Drug Evaluation and Research director are raising new concerns about more career staff attrition, which likely will negatively impact the drug industry.

US FDA User Fee Balances Holding, Thanks In Part To Earlier Staff Cuts

 
• By Derrick Gingery

An agency official said reserve user fee money is expected to continue funding application review and other activities for several more weeks.

GDUFA IV Talks Begin, Embracing Traditional Process

 
• By Derrick Gingery

The introductory meeting did not suggest changes to the expected schedule and operations for renewing the generic drug user fee, said AAM’s Giuseppe Randazzo.

More from Pathways & Standards

Where RWE Studies Stand In India And Bharat Serums’ Plans For The World’s Largest One

 
• By Vibha Ravi

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

Epilepsy Cell Therapy NRTX-1001 Among Trio Of Drugs To Win EMA PRIME Designations

 
• By Neena Brizmohun

NRTX-1001, taladegib and AZD0292 are the latest investigational products to make it onto PRIME, the European Medicines Agency’s priority medicines scheme for drugs for unmet medical needs.

Tidmarsh Creates More Instability And Uncertainty For US FDA, Industry

 
• By Sarah Karlin-Smith

The issues surrounding the FDA's Center for Drug Evaluation and Research director are raising new concerns about more career staff attrition, which likely will negatively impact the drug industry.