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 Drug Development Tool Guidance Leaves Door Open For Advisory Committee Reviews

Executive Summary

FDA’s proposed process for qualifying drug development tools allows for the convening of advisory committee meetings or other public discussions about complicated submissions involving proposed biomarkers or patient-reported outcome instruments.

You may also be interested in...



Biomarkers Qualification: Can FDA Get Rolling Before A Push From Congress?

FDA has been reluctant to lay out evidentiary standards for biomarker qualification, but its call for information on promising candidates may be an initial step toward creating such a framework.

What Not To Do: FDA Reviewer Talks Cancer Drug Development Mistakes

Using anonymous examples at the recent AACR meeting, FDA’s Tatiana Prowell highlights mistakes made and lessons learned in oncology drug reviews.

Disease-Of-The-Quarter Club: FDA Plans 20 Patient Network Meetings Over Five Years

PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.

Related Content

Topics

UsernamePublicRestriction

Register

PS052830

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

Cancel