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

US industry concerned about FDA's data falsification rule

This article was originally published in SRA

Executive Summary

The US pharmaceutical and clinical research industry has expressed serious concerns about a new rule proposed by the Food and Drug Administration, which, if finalised, would require sponsors to report to the agency about any individual who has, or may have, engaged in falsification of data in studies involving human or animal subjects1,2.

You may also be interested in...



FDA's Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident

Democratic senators push data-challenged gene therapy into maw of drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question US FDA's decision to withdraw the proposed rule last year.

EMA Launches First RWE Studies Under Big Data Project

The European Medicines Agency has partnered with eight institutions having access to real-world healthcare data to enable its DARWIN EU project to deliver real-world evidence to the EU medicines regulatory network when needed.

EU Refines Simultaneous Scientific Advice Pilot With Focus On Clinical Trials

Improvements have been made to the second phase of an EU pilot that allows drug sponsors to obtain simultaneous scientific advice from two member states.

Latest News
See All
UsernamePublicRestriction

Register

PS115347

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