Pink Sheet is part 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 Implementation May Sap Resources From Product Review, CBER Says

Executive Summary

Implementation of the International Conference on Harmonization's Common Technical Document could temporarily drain resources from product review, Center for Biologics Evaluation & Research Associate Director for Review Management Robert Yetter, PhD, warned.

You may also be interested in...



CTD Submission Voluntary, But Recommended Instead Of NDA Format

Common technical document submission will remain voluntary, but recommended, according to FDA's draft guidance on general considerations regarding CTD submission.

CTD Submission Voluntary, But Recommended Instead Of NDA Format

Common technical document submission will remain voluntary, but recommended, according to FDA's draft guidance on general considerations regarding CTD submission.

ICH To Address Postmarketing Issues As Possible Topic At May Meeting

Postmarketing issues surrounding drug products will be taken up as a new topic for consideration at the May meeting of the International Conference on Harmonization Steering Committee in Tokyo.

Related Content

UsernamePublicRestriction

Register

PS038120

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