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

Good Review Management Guidance Splits Responsibility Between Sponsors & FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Final document decreases the draft's emphasis on pre-submission activities, noting that development is primarily sponsor's domain; submission shifts application management responsibility to FDA. Guidance outlines "model review management practices" and provides detailed links to relevant regulations.

You may also be interested in...



FDA’s Good Review Management Practices To Debut In “Near Future”

Even as the agency wrestles with the transformation brought by FDAAA, shifts in how it processes NDAs may be the "most important," CDER official says.

FDA’s Good Review Management Practices To Debut In “Near Future”

Even as the agency wrestles with the transformation brought by FDAAA, shifts in how it processes NDAs may be the "most important," CDER official says.

Most Recipients Of 74-Day Letters Believe They Facilitate Product Review – PhRMA Survey

Survey about 74-day letters and other good review management practices issues is previewed at DIA’s annual meeting in Atlanta..

Related Content

Topics

UsernamePublicRestriction

Register

PS061881

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