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

A Regulator’s Perspective For 2013: FDA’s Temple Discusses FDASIA, Caronia, and Breakthrough Development

This article was originally published in RPM Report

Executive Summary

FDA’s dean of drug development Robert Temple offered his perspective on a number of different issues facing the agency and the drug industry at The RPM Report’s FDA/CMS Summit, including the impact of FDASIA, the Caronia off-label promotion ruling, and new approval pathways. Below is an edited transcript of his comments.

You may also be interested in...



FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?

Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?

First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It?

FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.

The Consequences of Caronia: Impact On FDA’s Off-Label Regulation

The government has decided not to appeal the Second Circuit’s Caronia off-label promotion ruling – no doubt in part because of concerns about the broad reading of the First Amendment currently in favor at the Supreme Court. Officially, FDA has adopted a low-key response. Unofficially, agency officials – notably Bob Temple – are outraged by the ruling. What does Caronia mean for the future of FDA regulation and off-label prosecutions?

Related Content

Topics

UsernamePublicRestriction

Register

PS081082

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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