Correspondence: Lawrence X. Yu, Food and Drug Administration, Office of Generic Drugs, 7500 Standish Place, Rockville, MD 20855, USA. Tel: +1 240 276 9310; Fax: +1 240 276 9327; E-mail: Lawrence.Yu@fda.hhs.gov

¹is Director for Science, Office of Generic Drugs, Food and Drug Administration.

²is Chemist, Office of Generic Drugs, Food and Drug Administration.

³is Chemical Engineer, Office of Generic Drugs, Food and Drug Administration.

⁴is Chemist, Office of Generic Drugs, Food and Drug Administration.

⁵is Pharmacologist, Office of Generic Drugs, Food and Drug Administration.

⁶is Associate Director, Office of Generic Drugs, Food and Drug Administration

⁷is Director, Division of Chemistry I, Office of Generic Drugs, Food and Drug Administration.

⁸is Director, Division of Chemistry II, Office of Generic Drugs, Food and Drug Administration.

⁹is Director, Division of Chemistry III, Office of Generic Drugs, Food and Drug Administration.

¹⁰is Deputy Director, Division of Chemistry I, Office of Generic Drugs, Food and Drug Administration.

¹¹is Deputy Director, Division of Chemistry II, Office of Generic Drugs, Food and Drug Administration.

¹²is Director, Office of Generic Drugs, Food and Drug Administration.

Received 9 March 2007; Revised 9 March 2007; Published online 1 May 2007.

Abstract

The US Food and Drug Administration Office of Generic Drugs has developed a question-based review (QbR) for the Chemistry, Manufacturing, and Controls (CMC) evaluation of an abbreviated new drug application (ANDA). This new QbR system incorporates quality by design and implements risk-based assessment. It recommends that ANDAs be submitted using the Common Technical Document and include the Quality Overall Summary (QOS) that addresses all the QbR questions. The main benefits of this QbR system are to (1) assure product quality through design and performance-based specifications, (2) facilitate continuous improvement and reduce CMC supplements through risk assessment, (3) enhance the quality of reviews through standardised review questions, and (4) reduce CMC review time when applicants submit a QOS that addresses the QbR questions. The QbR was partially implemented in 2006 and is being fully implemented in 2007.