1. Pink Sheet
  2. >>Product Reviews

US FDA's On-Time Review Decision Rates Slip During The Pandemic, Especially For Biosimilars

 
• By Derrick Gingery

Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.

Dam leaking
Is the dam starting to crack in the US FDA's pandemic review performance? • Source: Shutterstock

The US Food and Drug Administration’s biosimilar approvals appear to be the agency operation that is suffering the most under the strain of the coronavirus pandemic, but the FDA argues the drop in on-time actions is a function of the program’s relatively small sample size, not an inherent performance problem.

But with review timeliness also slipping a bit for the prescription and generic drug user fee programs over the last...

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 Product Reviews

More from Pink Sheet

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.