1. Pink Sheet
  2. >>Drug Safety

US FDA's Sentinel To Begin Expansion This Fall

 
• By Derrick Gingery

Contracts for up to $220m to develop three new Sentinel centers will be awarded in September.

Sentinel-Meerkats_1200x675
The FDA's Sentinel program has grown from a small pilot to a fully mature program. • Source: Shutterstock

The US Food and Drug Administration is reviewing proposals for a dramatic expansion of its Sentinel Initiative that would support new analysis methods, more data access and more drug safety and efficacy studies.

Sentinel, the FDA's electronic system that uses insurance claim, electronic health record (EHR) and other data to monitor the safety of drugs, biologics, vaccines and medical devices, would grow into...

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 Drug Safety

More from Pink Sheet

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.