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

Oncology ‘Beyond Breakthrough’ Takes Shape: FDA Project Will Create Benefits ‘Menu,’ Rescission Process

Executive Summary

US FDA’s oncology team has come to realize that a better understanding of how to personalize its ‘all-hands-on-deck’ approach would be even more helpful – especially for first-time sponsors.

You may also be interested in...



US FDA's Presubmission Expedited Regulatory Programs Eyed For Streamlining

Agency staff, stakeholders see advantages to bundling requirements for fast-track and RMAT designations into a single, pre-breakthrough therapy pathway, and codifying processes and interactions that take place following award of breakthrough designation; proposal is aimed at reducing current programs' redundancies and maximizing benefit of frequent, early interactions with the FDA.

CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence

US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.

Cures II Wish List: Reconsidering Accelerated Approval?

Richard Pazdur wants the oncology community to take a fresh look at US FDA’s expedited review programs. One big question: should there be fewer of them?

Topics

UsernamePublicRestriction

Register

PS144388

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