A group of prominent researchers created a transparency plan for the Food and Drug Administration “to advance the development of safe and effective new products.” Their report makes recommendations in five major areas: “The FDA should disclose more information about key milestones in the application process; …disclose more of its analysis and decision-making, …disclose more about the application and review process for generic drugs and follow-on biologics; …correct misleading information the the market; and …disclose data from scientific studies to enhance understanding of medical products.” (Science Daily, March 13, 2017)
At present the FDA will not reveal the details of letters sent when medical product applications are not approved, release the number or nature of pending applications or correct information in the public arena that they know is false. (RAPS, Regulatory Affairs Professionals Society, March 15, 2017, by Zachary Brennan)