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 Envisions Flexible Approach To Expanded Use Of Accelerated Approval

Executive Summary

In its desktop reference guidance on the four expedited regulatory pathways, FDA broadens its view of when an investigational drug fills an “unmet medical need” and guides sponsors through the use of intermediate clinical endpoints as a basis for accelerated approval.

You may also be interested in...



Redefining Accelerated Approval Criteria Would Expand Pathway’s Use, Panel Says

Expanding the definition of “unmet medical need” and adopting a narrow, molecularly targeted approach to determining the existence of “available therapies” would enable use of the approval pathway in earlier treatment settings, a group of stakeholders tells a cancer research conference.

FDA To Provide Expedited Approval Desktop Reference

Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.

FDA Drug Shortage Strategy: Enforcement Discretion, Patient Public Relations

Rapid approval of a new, preservative-free generic methotrexate and permission to import an unapproved version of doxorubicin touted at press conference as FDA emphasizes the success of administrative efforts.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134044

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