(607a) CMC Reviewer Expectations for ANDAs Using QbD Approaches

Iser, R. L. - Presenter, FDA/CDER/Office of Generic Drugs

There has been an increase in science and risk-based approaches under the Quality by Design paradigm in new drug submissions to the FDA.  There are particular challenges for generic drug manufacturers with respect to using QbD approaches, especially with more complex dosage forms, such as modified release (MR) products. In an effort to increase transparency with the generic industry and the pharmaceutical industry at large, this presentation will provide insight into CMC reviewer expectations when evaluating pharmaceutical development studies, the applicant’s process and product understanding, use of risk assessment tools, and proposed control strategies.