Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Question-Based Review (QBR) | Contract Pharma

What are you searching for?

Sign in

Question-Based Review (QBR)

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Method of CMC review for generic drugs (ANDAs) implemented by the FDA. According to the agency, “The QbR . . . incorporates the most important scientific and regulatory review questions that focus on critical pharmaceutical attributes essential for ensuring generic drug product quality. The QbR serves two purposes for the CMC assessment of ANDAs. First, it provides a guide to the reviewer in the evaluation of whether a product is of high quality and in the determination of the level of risk associated with the manufacture and design of the product. Second, it provides transparency to sponsors about the logic that reviewers invoke in their CMC reviews.”

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters