1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Biosimilars

US FDA Making BsUFA III Regulatory Science Grants Available Early

 
• By Derrick Gingery

Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.

Beaker with US money
The biosimilar regulatory science research pilot program is intended to resemble the FDA program already created for generic drugs. • Source: Alamy

The US Food and Drug Administration is soliciting applications for biosimilar regulatory science grants now even though the program most likely will not be created for a few more months.

The grants, available under the upcoming biosimilar user fee program reauthorization, are intended to “support research projects that enhance biosimilar and interchangeable biological product development and regulatory science,” according to the 

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 Biosimilars

More from Biosimilars & Generics

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

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.