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

Mandatory FDA Review Of Pivotal Trial Protocols Urged In JAMA

This article was originally published in The Pink Sheet Daily

Executive Summary

Dartmouth researchers say that although FDA recommendations can strengthen study designs and improve outcome measures, sponsors often don’t follow agency’s advice or don’t even seek input in Phase III design.

You may also be interested in...



Why Drugs Get Delayed: Blame It On Safety Concerns, Researchers Say

However, FDA allows manufacturers more leeway in providing additional data or new analyses to better understand a safety issue than an efficacy concern, according to a Health Affairs study of novel drugs approved after multi-cycle reviews.

“Breakthrough Therapies” Deserve Skepticism, Researchers Say

Although drugs on the FDASIA-created expedited pathway may promise more than they can deliver, it will be difficult to reduce demand for such treatments awarded the designation, Boston researchers predict in a NEJM piece.

Many Drug Approval Delays, Denials Could Be Prevented, FDA Study Shows

Agency reports preventable deficiencies, including failure to select optimal drug doses and suitable study endpoints, account for many drug rejections, approval delays.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS076675

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