FDA progress/timeline --- agency transparency efforts in the US pharma industry
Article List
- FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes
March 26, 2020 - Federal register notice: New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication; Notice; Request for Comments
June 26, 2019 - FDA-in-Brief: FDA seeks public feedback on new drug approval transparency efforts
June 26, 2019 - FDA's Clinical Data Summary Pilot Program: Questions Frequently Asked by Industry
May 2, 2018 - FDA Voice Blog: FDA’s New Pilot Program Aims for More Transparency about New Drug Approvals
March 19, 2018 - FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs
January 16, 2018
