Pink Sheet is part of the Business Intelligence Division 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


Biomarker Development Meeting May Help Expand Accelerated Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA could develop more guidance on how sponsors can qualify potential surrogate endpoints.


Related Content

Biomarkers: FDA Working To Define 'Reasonably Likely To Predict' Standard
Research Consortia Need Funding, But FDA Is More “Honest Broker”
FDA Flexible With Accelerated Approval Evidence, Analysis Finds
Biomarkers In Orphan Studies Still Need Past Experience, FDA Says
Paging Dr. McClellan: FDA Calls On Brookings For PDUFA Research
For Combination Product Development, Industry Says Talk Is Cheap
PDUFA V: Final Recommendations Fund Proposals In Two Of Three Tiers





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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