1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Approval Standards

Real-World Evidence Demo Projects From US FDA To Include New Mobile App

 
• By Sue Sutter

Agency releases open source code and technical documents for new mobile app designed to gather real-time information about medication use and patient-reported outcomes; app will be incorporated into several PCORI-funded studies that FDA is leveraging as it explores the regulatory utility of real-world data.

Young woman using a touchscreen smartphone.

The US FDA’s real-world evidence (RWE) demonstration projects will feature a new mobile app developed by the agency and its partner in the Sentinel active surveillance system, Harvard Pilgrim Health Care Institute, aimed at making it easier to collect data from patients.

The FDA MyStudies app is a tool to gather real-time, contextual data about medication use and other health issues facing...

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 Approval Standards

US FDA Gives Leucovorin Unprecedented Path To New Claim Amid ‘Autism Crisis’

 
• By Bridget Silverman

The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.

More NME Reviews, Reduced Costs Combine To Lower US FDA Voucher Fee

 
• By Derrick Gingery

The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.

US FDA Complete Response Letters Offer ‘Path Forward’ To Approval

 
• By Sue Sutter

Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.

US FDA Complete Response Letters Raise Confirmatory Evidence Shortfalls

 
• By Sue Sutter

The agency identified deficiencies in efficacy evidence intended to support results from a single adequate and well-controlled trial for orphan applications, including weaknesses in animal data and insufficient quantity and quality of biomarker data.

More from Pathways & Standards

US Congress Gives Rare Pediatric Disease Voucher Program Renewal Another Try

 
• By Sue Sutter

The Give Kids A Chance Act would renew the PRV program that began to sunset in December 2024. The House Energy and Commerce Committee advanced the pediatric- and rare disease-focused package, but also included generic drug transparency provisions.

US FDA Complete Response Letters Offer ‘Path Forward’ To Approval

 
• By Sue Sutter

Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.