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

CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.

You may also be interested in...



FDA's Combo Products Review Transformation Begins

Pilot project sets timelines for lead and consulting centers that will feed into more substantial changes in PDUFA VI.

Senior CDER Management Panel Could Facilitate Novel Therapy Approval

CDER Director Janet Woodcock is creating an executive-level forum to deliberate medical policies, including those needed to smooth drug reviews. She envisions stakeholder input on topics for discussion by the panel.

Antisense Oligonucleotide Clinical Guidance Emphasizes Individualized Nature Of Treatment

US FDA’ s latest ‘n of 1’ guidance describes clinical considerations for INDs to support dosing and monitoring of an individual with a life-threatening genetic disease who is eligible to receive an ASO; recommendations apply only when a few patients may be candidates for treatment.

Topics

UsernamePublicRestriction

Register

PS005418

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