Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

ICH Takes Flexible Approach On Presenting Benefit-Risk Assessment In Drug Submissions

Executive Summary

The International Council for Harmonisation's final guidance on standardizing benefit-risk information in drug submissions is expected to support regulatory decision-making through a more consistent description of information.

Advertisement

Related Content

ICH: India, Mexico And Russia Among New Observers; Benefit-Risk Guideline Adopted
ICH Consults On Standardizing Benefit-Risk Information In CTD Drug Submissions

Topics

Advertisement
UsernamePublicRestriction

Register

PS118834

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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