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

OGD issues update on question-based review (QbR) submissions

This article was originally published in The Gold Sheet

Executive Summary

OGD reports that in July 2007, more than 90 percent of ANDA submissions met the goal of including quality overall summaries that addressed all of the questions in the QbR. QbR is an assessment system focused on critical quality attributes which will assess a sponsor's implementation of the FDA's GMPs for the 21 Century and quality by design initiative
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS000110

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