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

Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods

Executive Summary

As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures, which applicants for drug approvals and biologics licenses could use to reduce method validation requirements. Pfizer undertook the first commercial application of the platform analytical approach, which is widely used in development.

You may also be interested in...



Quick And Flexible Vaccine Approval Must Include Postmarket Simplicity, US FDA’s Kaslow Says

After making the COVID-19 vaccines available, multiple presentations based on age and vaccination status created confusion that likely hindered uptake, said OVRR Director David Kaslow.

Sen. Burr’s Parting Gifts For US FDA Include ‘Platform’ Pathway

The year-end package of US FDA reforms reflects the impact of one now-retired US Senator: North Carolina’s Richard Burr’s objections helped take out a number of ‘anti-innovation’ provisions – while still securing inclusion of a ‘Platform Technologies’ pathway that might otherwise not have been enacted.

ICH Proposals Would Streamline Analytical Technology Adoption

ICH regulatory members will seek input on guidelines that bring quality-by-design concepts to the development and evolution of the analytical methods required for release of drug products.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149889

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