FDA-TRACK: Center for Biologics Evaluation and Research - Goal 2

 

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• Goal 1:Review Measures, Recalls, Lot Distribution Data, Adverse Events

• Goal 2: Research Lab Site Visits

• Goal 3: MCM Development, International Collaboration Projects

• Goal 4: Conflict of Interest Waivers, PMAP Measures

Relevant Links:

1. 1. CBER 2021-2025 Strategic Plan
2. 2. 21st Century Cures Act

FDA's Center for Biologics Evaluation and Research (CBER) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

CBER’s research program must keep pace with the rapid innovation in biologics to ensure that CBER’s regulatory decisions and policy-making are informed by the latest science and technology. To achieve this goal, CBER will continue to maintain a robust scientific infrastructure to support key scientific activities by ensuring that CBER’s labs and core research facilities remain up to date with emerging technology.

Goal 2: Conduct Research to Address Challenges in the Development and Regulatory Evaluation of Medical Products

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Download Goal 2 Dataset

Note:  The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons.