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

Would Sponsors Do Earlier Pediatric IBD Studies With Nod From Agency Or Advisory Committee?

Executive Summary

Including adolescents in adult studies was one option for obtaining information on inflammatory bowel disease therapies’ efficacy and safety in children discussed at a two-day FDA and professional society workshop.

You may also be interested in...



Pediatric IBD Studies Should Assess Disease Activity, Panel Says

Clinicians tell FDA that focusing solely on symptoms as an endpoint for pediatric ulcerative colitis and Crohn’s disease ignores the long-term deleterious effects of inflammation. Panel stresses the need to include growth as an endpoint and to conduct pediatric studies earlier.

Pediatric Study Plans Would Be Required At End Of Phase II Under Bipartisan House Bill

Rather than assessing monetary penalties for violating study deadlines, H.R. 4274 directs FDA to issue warning letters and publish them on its website.

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

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055708

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