Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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 FDA Suggests ‘Enhancements’ To Opioid Blueprint; CE Providers Want ‘Flexibility’

Executive Summary

The US FDA has some ideas for short-term improvements in the continuing education “blueprint” used as part of the opioid class REMS. Providers want more dramatic changes to the CE model itself.  

You may also be interested in...



Opioid REMS Revisions Reflect Some, Not All, Stakeholder Concerns

US FDA's education blueprint now asks sponsors to extend REMS to health providers beyond prescriber, but pain classifications remain unchanged.

End Of ‘Phase I’: The Case To Re-Name First-In-Human Oncology Trials

US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.

Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization

The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.

Topics

UsernamePublicRestriction

Register

PS146018

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