In Vivo 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

McClellan, Wall Street and Increasing FDA Predictability

Executive Summary

The most encouraging aspect of the series of speeches the FDA's new commissioner, Mark McClellan, MD, PhD, has been giving is not what he says--we've heard most of this before--but to whom he says it: pharmaceutical investors and companies.

You may also be interested in...



FDA to Run Pilots Designed to Reduce Total NDA Review Time

Beginning in October, the FDA plans to test possible solutions designed to curtail multiple-cycle reviews--but it needs drug developers' help. The agency wants sponsors with fast-track product candidates to volunteer for two pilot programs--part of the Continuous Marketing Application (CMA) initiative--designed to assess both rolling application reviews and earlier, more frequent FDA-industry interactions.

FDA to Run Pilots Designed to Reduce Total NDA Review Time

Beginning in October, the FDA plans to test possible solutions designed to curtail multiple-cycle reviews--but it needs drug developers' help. The agency wants sponsors with fast-track product candidates to volunteer for two pilot programs--part of the Continuous Marketing Application (CMA) initiative--designed to assess both rolling application reviews and earlier, more frequent FDA-industry interactions.

Pharmacogenomic Data and Labeling: A Less-Safe Harbor for Existing Drugs?

At the same time that FDA is taking pains to assure companies that pharmacogenomics data won't affect the review process for new drugs unless the agency and the sponsor first agree on the meaning of those data, it's also thinking of taking a tougher position with existing drugs.

Related Content

Topics

UsernamePublicRestriction

Register

LL111109

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