1. Pink Sheet

US FDA Integrated Assessment Roll-Out Expanding By End Of 2021

 
• By Derrick Gingery

All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.

Stacks of paper
The integrated review is intended to streamline FDA product approval packages, which can number in the hundreds of pages. • Source: Alamy

Sponsors should notice more widespread use of the integrated assessment concept within US Food and Drug Administration review divisions later this year, and potentially the growing pains that may come with it.

The integrated assessment is intended to encourage more collaboration among FDA assessors. The process includes the controversial combined review where...

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

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 
• By Urtė Fultinavičiūtė

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.