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

Making sense of clinical trial data disclosure in the EU

This article was originally published in SRA

Executive Summary

You may also be interested in...



EMA Appeals Interim EU Court Orders Preventing Access To Documents

The European Medicines Agency is looking for a clear indication from the EU courts on whether its approach to transparency – as defined in its access to documents policy – is correct.

US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation

CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach. 

New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments

Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118169

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