New FDA ‘Transparency Roadmap’ foreshadows major changes to trial data and more

By Alexander Gaffney, MS, RAC, Amanda Conti and Laura DiAngelo, MPH

FDA has unveiled a new “Transparency Roadmap” outlining plans for greater disclosure across clinical and nonclinical data, regulatory applications, inspection records and other areas. The roadmap also offers new signals about forthcoming policies involving drug labeling and advertising.

But significant questions remain around what information FDA will disclose, when it will be released and how the agency will protect confidential commercial information.

This AgencyIQ analysis examines the most consequential elements of FDA’s transparency push, the practical and legal questions it raises and what regulated companies should be watching as the agency moves toward implementation.

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