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GEN Poll

March 16, 2017

FDA Transparency

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.

A group of researchers calls for more transparency at the FDA and say that the agency should disclose more information about key milestones in the application process, more of its own analysis and decision-making, more about the application and review process for generic drugs and follow-on biologics, data from scientific studies to enhance understanding of medical products, and correct misleading information in the market.

Do you agree that more transparency at the FDA is needed?

 
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