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’s Streamlined Review Pilot Takes Flight; Second Oncology sNDA Through Process

This article was originally published in RPM Report

Executive Summary

FDA’s Office of Hematology & Oncology Products will complete four to five streamlined reviews of supplemental oncology indications before reflecting on the “lessons learned” from the pilot program. After the successful review of Genentech’s Avastin for cervical cancer, FDA says that a second application has gone through the abbreviated process.

You may also be interested in...



Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

US FDA commissioner outlines plans to allow partial submissions as soon as database locks and to create joint sponsor-agency review documents.

Immuno-Oncology’s Revolutionary Impact – On US FDA

Unprecedented wave of cancer immunotherapies is in some ways a mirror image of AIDS crisis as FDA explores new tools to accelerate drug development, including modeling techniques and statistical approaches to efficacy. It's an effort to encourage a regulatory revolution in response to a massive number of products in development as opposed to the AIDS-era effort to get products studied.

CBER Will Staff Up With 100 More Reviewers ‘By Hook Or By Crook,’ Marks Says

US biologics center is getting back to regular business now that COVID-19 work is subsiding; director Marks credits acting commissioner Woodcock with using all available mechanisms to staff up.

Topics

Related Companies

UsernamePublicRestriction

Register

PS079829

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