Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


FDA Creates CMC Pilots To Put Quality Assessment Principles Into Practice

This article was originally published in The Pink Sheet Daily

Executive Summary

NDA and ANDA pilot programs will help transform the way CMC information is submitted and reviewed by FDA. Office of Generic Drugs' white paper on "question-based review" follows the introduction of an NDA pilot program in mid-July.

You may also be interested in...

Industry Views On Quality-By-Design, Specifications To Be Presented At Cmte. Meeting

PhRMA, GPhA and USP will make presentations at Oct. 25-26 meeting of the Advisory Committee for Pharmaceutical Science. Question-based review for quality assessment will also be discussed.

GMP “Design Space” To Facilitate FDA Quality Initiative Implementation

“Design Space” is emerging as a pivotal concept in FDA’s effort to integrate its pharmaceutical application review and inspection operations into a new “quality assessment” system. With regulatory flexibility for manufacturing changes in the balance, the agency will be working with industry to refine the concept and its application in drug development and manufacturing.


Latest News
See All



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