Posted on 06 Apr 2020


FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

After soliciting opinion on how FDA might best support disclosure of clinical documents and announcing the conclusion of its Clinical Data Summary Pilot on 26 March 2020, FDA is not currently disclosing clinical documents but has identified a possible approach for disclosing study reports, the framework of which includes the following principles:

  • A centralised international library managed by an independent body would be set up where information is made available to the public, rather than each regulatory authority having its own system
  • An on-demand system would be set up where some documents, e.g. clinical summaries, index of study reports, would be automatically published. The public could request documents and the sponsors would add them to the library
  • Anonymisation and disclosure standards would apply; PhUSE standards are particularly mentioned
  • Sponsor commitment to use the international library system would be voluntary.

This RAPS article is an interesting perspective on the development of FDA’s thinking.