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

Better Clinical Trial Safety Data Would Aid Benefit/Risk Analysis – DIA Europe Panel

This article was originally published in The Pink Sheet Daily

Executive Summary

More work needs to be done on benefit/risk assessments before Phase II/III, industry reps say.

You may also be interested in...



FDA’s Risk/Benefit Decisions Will Be Quantified With Metric From Contractor

A recent request for proposals may signal a shift in FDA's approach to risk/benefit analysis and views on outcome measures, a move some see as bringing more transparency while also shielding the agency from criticism

Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says

Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS067526

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