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 Emphasizing Written Communication With Sponsors On Pending NDAs

Executive Summary

FDA will emphasize official written action letters in its internal policy on communication with sponsors drafted in response to the Congressional investigation of the Erbitux review, Acting Commissioner Crawford said Oct. 10

You may also be interested in...



Good Review Management Guidance To Be Tested By “Root Causes” Analysis

FDA will evaluate the impact of its Good Review Management Principles project through a prospective analysis of NME submissions, beginning with fiscal year 2005

Good Review Management Guidance To Be Tested By “Root Causes” Analysis

FDA will evaluate the impact of its Good Review Management Principles project through a prospective analysis of NME submissions, beginning with fiscal year 2005

PhRMA Feels Deadline Pressure, Reminds FDA Of Flexibility In PDUFA Goals

The Pharmaceutical Research & Manufacturers of America is suggesting that FDA can miss its user fee deadline for a product if prolonging the review would lead to swifter approval than entering a second cycle

Related Content

UsernamePublicRestriction

Register

PS040612

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