ANDA常见缺陷系列综述Part I.pdf

FDA Perspectives: Common Deficiencies in Abbreviated New Drug Applications: Part 1: Drug Substance Team leaders in FDAs Office of Generic Drugs provide an overview of common deficiencies cited throughout the CMC section of abbreviated new drug applications. Jan 2, 2010 By: Aloka Srinivasan, Robert Iser Pharmaceutical Technology Volume 34, Issue 1, pp. 50-59 The ever increasing workload at the Office of Generic Drugs (OGD) within the US Food and Drug Administrations Center for Drug Evaluation and Research (CDER) has led the office to develop a number of strategies to streamline the review process. One such strategy was the introduction of Question- Based Review–Quality Overall Summary (QbR–QOS). Another strategy involves asking sponsors of abbreviated new drug applications (ANDAs) to provide a Pharmaceutical Development Report with their application. The QbR is a platform for implementation of CDERs Pharmaceutical CGMPs for the 21st Century: A Risk- Based Approach and a springboard to quality by design (QbD). It also provides the sponsors with an opportunity to discuss the development of their product. The summary report in QbR-QOS can be referenced by the reviewers as a snapshot of the ANDA before they review the entire application (i.e., the body of data). Adequate information provided in the QbR–QOS and the Pharmaceutical Development Report reduces the application assessment time, minimizes transcriptional errors, and helps the review process at all levels (primary, secondary, and tertiary). Examples of commonly cited drug-substance related deficiencies in ANDAs (as paraphrased by the authors) Also, by seeking sponsors