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

FDA Will Accept Common Technical Document Instead Of NDA In July 2001

Executive Summary

FDA will begin accepting drug applications in the Common Technical Document format presented as early as July 2001.

You may also be interested in...



ICH Harmonized Global Stability Testing Recommendations Sought By PhRMA

The Pharmaceutical Research & Manufacturers of America and the European Federation of Pharmaceutical Industries Associations have convened a working group to establish harmonized global stability testing recommendations for drug products across climatic zones

ICH Harmonized Global Stability Testing Recommendations Sought By PhRMA

The Pharmaceutical Research & Manufacturers of America and the European Federation of Pharmaceutical Industries Associations have convened a working group to establish harmonized global stability testing recommendations for drug products across climatic zones

ICH Guidance To Clarify Submission Of Integrated Safety, Efficacy Summaries

FDA plans to clarify in a guidance what companies should include in integrated summaries of safety and efficacy in common technical document submissions

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS036914

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