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As the new administration considers the future direction of the Food and Drug Administration, a group of researchers has created a Blueprint for Transparency at the agency to advance the development of safe and effective new products. They published an overview of the Blueprint in JAMA that makes 18 recommendations in five principal areas:
The FDA should 1) disclose more information about key milestones in the application process; 2) disclose more of its own analysis and decision-making; 3) disclose more about the application and review process for generic drugs and follow-on biologics.4) disclose data from scientific studies to enhance understanding of medical products; and 5) correct misleading information in the market.