Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

ICH Expansion To Bring New Challenges For Global Consensus On Pediatric Extrapolation

Executive Summary

The pharmaceutical industry is cautiously optimistic about the ambitious three-year timeline decided by the International Council for Harmonisation for its new guideline on pediatric extrapolation. However, ensuring consensus on this fast-developing concept will be a challenge as more regulators will have a seat at the discussion table as ICH expands.

You may also be interested in...



Orphan Designations For Pediatric Subgroups Of Common Diseases To End

US FDA's draft guidance closes loophole where sponsors could obtain an orphan designation for a pediatric subset and then be exempt from requirements to conduct pediatric studies.

ICH Expansion Prompts WHO To Review Definition Of 'Stringent Regulatory Authorities'

European research-based pharmaceutical industry association, EFPIA, says it "makes sense" for the World Health Organization to review the concept of "stringent regulatory authorities," which is linked to a country's membership of the International Council for Harmonisation.

Final ICH Addendum Offers Latest Perspectives On Pediatric Drug Development

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

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS121820

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel