Sentinel May Expand To Generic Equivalence Studies

Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.

The US FDA's Sentinel system eventually may grow to help assess generic drug equivalence and improve its ability to find safety problems.

Sentinel has commissioned researchers to develop a tool to characterize product utilization and switching patterns, including between brand drugs and generics. The tool will capture switching at the manufacturer level...

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 Generics

More from Biosimilars & Generics

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By 

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.