GDUFA: Fee Avoidance Affects Rates Again

Industry avoided application supplement fees by using CBE submissions instead, forcing FDA to change its estimates and sending generic drug user fees higher.

A change in the type of generic drug application sponsors submit to reflect moderate manufacturing process or other changes may have significantly affected GDUFA user fees.

Much of the increase in the fiscal year 2014 generic drug user fees was attributed to a rebalancing of the burden to compensate for the loss of a fee for...

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

More from United States

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By 

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By 

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

More from North America