How US FDA's Assumptions Impacted Generic Program Fees

FDA decided against trying to predict upcoming approvals as part of FY 2019 GDUFA program fee calculations, but other adjustments likely increased fee significantly.

FDAEntrance_1200x675

The US FDA decided not to adjust the FY 2019 GDUFA program fee to account for firms that could jump tiers in the middle of the fiscal year, potentially saving ANDA owners some money.

FDA also changed a variable that was used in its calculations, another example of FDA learning how to use its...

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 US FDA

More from Agency Leadership

Swissmedic Appoints Trivigno As New Agency Head From 2026

 

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
• By 

The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.