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

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.

Postmarketing Safety Gets Closer Focus In Latest US FDA Drugs Center Reorganization

Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.

Topics

UsernamePublicRestriction

Register

OM004674

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