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
UsernamePublicRestriction

FDA Priority Review Status Refusals Show Need For Clinical Outcomes Data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sponsors who plan to seek priority review status need to show a superior effect on clinical outcomes, an examination of priority review requests rejected by FDA suggests

You may also be interested in...



FDA Required Outcomes Data For Cleviprex Priority Review, Proposed Label

FDA’s determination that The Medicines Company’s Cleviprex did not actually show a significant benefit over other intravenous antihypertensives caused the agency to make a rare move, and downgrade the application from a priority to a standard review.

Takeda Rozerem Clinical Significance Debated In FDA Review

The "curious" failure of subjective secondary endpoints to agree with the efficacy of Takeda’s Rozerem on objective sleep measures contributed to a debate at FDA over the clinical significance of the insomnia therapy.

Tarceva Pancreatic Cancer sNDA Planned For 1H05; Avastin Combo To Follow

Topics

UsernamePublicRestriction

Register

LL1135972

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