Scrip 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
This article was originally published in Scrip
The European Medicines Agency has abandoned plans to routinely require and re-analyze original clinical trial data in marketing authorization applications. Instead, it is considering whether it should restrict this exercise to a limited number of cases where "such analysis could significantly strengthen the [EMA's] assessment work".
| Table |
|---|
Ask the Analyst is free for subscribers. Submit your question and one of our analysts will be in touch.
Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.
All fields are required.
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.
