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**A Message from the CBER Centre Director **

On behalf of the Center for Biologics Evaluation and Research (CBER), I am pleased to present the Center’s strategic plan for the years 2021 through 2025, which outlines the direction that we will take to support and achieve our mission and vision over the next five years. This is an exciting time to be CBER’s Director, with science and technology advancing at an unprecedented rate. Evidence is emerging that we can evaluate and incorporate into our work to streamline our regulatory processes with the ultimate goal of accelerating the approval of safe and effective innovative medical products.

CBER’s strategic plan is based on our mission and vision, and outlines the goals, objectives, and strategies designed to further our mission and vision during the term of the strategic plan. Our plan aligns with HHS and FDA priorities and new authorities provided through the 21st Century Cures Act. It reflects the contributions of all Offices and Divisions, and sets forth the Center’s four goals:

• Goal 1: Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
• Goal 2: Conduct research to address challenges in the development and regulatory evaluation of medical products
• Goal 3: Increase preparedness for emerging threats and promote global public health
• Goal 4: Manage for strategic excellence and organizational accountability

Furthermore, the strategic plan reflects CBER’s current priorities for the near term:

• Priority 1: Addressing the COVID-19 outbreak
• Priority 2: Developing a regulatory program for individualized or bespoke therapies
• Priority 3: Facilitating compliance with human cells, tissues, and cellular and tissue-based product regulations
• Priority 4: Advancing manufacturing technologies for biologic products

New scientific advances give us the opportunity to reduce the burden of disease by bringing patients safe and effective novel products to prevent and treat diseases. At CBER, a fundamental part of our mission and vision is helping to provide the scientific foundations and the regulatory framework that will maximally expedite the translation of new scientific advances into such benefits for individuals and for the public health.

We view this strategic plan as a living document that will allow us to modify our direction and approach in order to address new regulatory challenges and obligations as the need arises, such as in the case of the current pandemic. Together, these goals, objectives, and strategies put CBER in the position to contribute to improving public health in the years to come. We have a clear direction and look forward to rising to the challenge of building on our successes to serve the American public.

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