1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Final ICH Addendum Offers Latest Perspectives On Pediatric Drug Development

 
• By Vibha Sharma

A new document that complements the International Council for Harmonisation's existing guideline on pediatric clinical trials is expected to reduce the likelihood of significant differences among countries on the acceptance of data generated in pediatric global drug development programs

Toy dog
ICH’s High-Level Document Addresses Pediatric Trial Issues • Source: Shutterstock

The International Council for Harmonisation has finalized a high-level document to complement and further clarify its E11 guideline on the clinical investigation of medicinal products in the pediatric population.

The new document, E11(R1), has been issued as an addendum to the guideline, which has been in place...

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 Clinical Trials

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By Sue Sutter

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 
• By Anabel Costa-Ferreira

Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.

EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

More from R&D