A Look Ahead at Manufacturing and Regulation - Pharmaceutical Technology

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A Look Ahead at Manufacturing and Regulation
FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.


Pharmaceutical Technology
Volume 37, Issue 1, pp. 40-47, 54

Role of CERSIs

PharmTech: One way to improve regulatory science (from a drug review standpoint) is to work with the industry directly to identify and fill in scientific and technological gaps that exist across drug development and manufacturing. FDA has created a few grant-based CERSIs, specifically with Georgetown University (GU), the University of Maryland (UMD), and the State of Arkansas. Will the agency be opening any additional centers of excellence?

FDA : We hope in future to fund one to two additional CERSIs, outside the region, but if and when, depends on availability of funding.

PharmTech: Can you comment on the staff training workshops held to date with these centers and their benefit to agency reviewers?

FDA : Agency reviewers have had the opportunity to participate in training events sponsored by both UMD and GU CERSIs. These events have provided continuing medical education to staff and opportunities to network with leading researchers from around the country. Additionally agency reviewers have also had the opportunity to maintain their scientific and medical skills by participating in clinical work, research, or teaching opportunities at UMD and GU CERSI.

Advancing regulatory science

PharmTech : Section 1124 of FDASIA states that the US HHS Secretary should have a strategy and implementation plan 'for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decision-making' by July 2013. What is FDA's role?

FDA : FDA is taking the lead in developing the Strategy and Implementation Plan for Medical Products as required in Section 1124 of FDASIA.

PharmTech: Are any additional major goals expected beyond FDA's current strategic plan surrounding regulatory science?

FDA : No, FDA expects to stay within the framework outlined in the Strategic Plan for Regulatory Science. The major areas of focus outlined in the Strategic Plan for Regulatory Science identify broad areas where advances in regulatory science are needed and are thus quite comprehensive. It is expected that the annual progress reports, which will follow in 2014 and 2016, will include more detailed information on specific accomplishments related to regulatory science.


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