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U.S. Department of Health and Human Services

Drugs

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OGD Update on Question-based Review Submissions

The Office of Generic Drugs (OGD) developed a Question-based Review (QbR) for its Chemistry, Manufacturing, and Controls (CMC) evaluation of Abbreviated New Drug Applications (ANDAs). QbR is an assessment system, focused on critical pharmaceutical quality attributes, which will concretely and practically assess a sponsor’s implementation of FDA’s cGMPs for the 21st Century and Quality by Design Initiatives. OGD intended the QbR implementation process to have goals that were SMART (Specific, Measurable, Acceptable, Realistic, and Timely). As QbR represents a significant change for ANDA sponsors, much effort was focused on education and communication and measuring the response to this outreach.

OGD began publicizing its QbR approach in 2005 and has communicated the changes to stakeholders through various workshops, webcasts, meetings, and individual industry talks.  In early 2006, OGD posted two example QbR submissions on their webpage.  From October to December 2006, OGD gave three workshops on how to prepare an effective Quality Overall Summary (QOS) and provided additional QbR training at the GPhA ANDA Basics Course in May 2007. On April 11, 2007, OGD and GPhA held a webcast meeting to discuss the progress of QbR and to further explain OGD’s expectations for submitting quality by design ANDAs. A Frequently Asked Question document about QbR was added to the OGD website on June 7, 2007.

As of January 2007, OGD encouraged ANDA sponsors to submit a Quality Overall Summary that answered the QbR questions with every ANDA submission. In July 2007 more than 90% of ANDA submissions met this goal. QbR submissions are an essential part of OGD’s efforts to improve the efficiency of the review process and encourage implementation of quality by design. The rapid and nearly complete transition to QbR submissions indicates the commitment of both OGD and ANDA sponsors to the new pharmaceutical quality assessment system.

Bar graph of QBR Sumissions showing percentage of ANDA's from January through July in 2007