I recently ran across a presentation from FDA that summarized the recommendations and steps for QbD elements in Abbreviated New Drug Applications (ANDA): Generics starting in January 2013. In order to help industry the FDA has provided examples of the types of studies ANDA applicants may use as they implement QbD.
What really interests me most was the establishment of Control Strategies as part of the QbD. In and of itself it’s not unexpected as part of any QbD program. However the deliberate application to generics signals a change in the agency thinking in my opinion. What are your thoughts on QbD being required in ANDAs ?
For a copy of the FDA presentation:
QbD Status Update Generic Drugs, October 3-5, 2011
For a copy an example development report:
Quality by Design for ANDAs: An Example for Modified Release Dosage Forms