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

FDA's Temple of Wisdom: The Dean of Drug Development

This article was originally published in RPM Report

Executive Summary

FDA will have new money and new authority before the year is out. But translating the new drug safety reforms into practice will be the responsibility of some old hands, including the Robert Temple, the dean of FDA's drug review group. The question drug companies should have: What is he thinking?

You may also be interested in...



The Return of The Pazdur Moment

US FDA’s top cancer drug reviewer has been uncharacteristically quiet during recent advisory committee meetings. That just changed, and the result may not have been great for the sponsor (Pfizer), but it is a reminder of the value that Pazdur’s institutional knowledge and outspokenness bring to all of FDA.

The Regulator and the Regulated Part I: A Conversation with FDA's Robert Temple and Amgen's Roger Perlmutter

FDA’s dean of drug development Robert Temple and Amgen’s head of research and development Roger Perlmutter sat down for a conversation at the recent FDA/CMS Summit to discuss opportunities and challenges for biopharmaceutical developers in the current regulatory environment.

Separate But Equal: FDA Reaffirms Drug Safety Role in Approval Process

There's a new drug safety structure at FDA, with the Office of Surveillance & Epidemiology gaining greater influence in how the agency manages things like REMS and product withdrawals. In many ways, it's a codification of an existing relationship between safety and review officials. But some sponsors worry it will also result in a less friendly approval process.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS080269

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