June 2019: United States Regulatory Update

FDA Requests Feedback on Pilot CSR Program & New Integrated Review Process

In a June 26th press release, FDA announced the issuance of a June 27th Federal Register notice to open a docket for public comment as part of the agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process for drug and biological products assessed by the FDA’s Center for Drug Evaluation and Research (CDER). The Federal Register notice specifically asks for feedback on:

The fledgling CSR pilot program launched in January 2018 that sought to provide more transparency on sponsors’ clinical study reports (CSRs) only resulted in the release of one CSR (Janssen was the only sponsor that agreed to participate).  The agency is considering whether to focus its efforts to better communicate the basis for drug approvals on the development of these new integrated review documents, rather than on the release of CSRs.

Clinical Data Summary Pilot Questions

Please see the CSR posting available on FDA’s Clinical Data Summary Pilot Program web page at:


  1. How did the CSR posted in this Pilot affect or compare with your understanding of the CSRs submitted to FDA by drug sponsors?
  2. How usable and/or accessible was the information in the CSR that was posted for the Pilot?
  3. Did the required redactions/ removal of certain information from the posted CSR affect your understanding or use of the posted information?
  4. How might the information/content posted from this Pilot be used? What other information/content would have been helpful?
  5. Given the other review documents available (e.g., FDA’s action package), how did the posted CSR affect your understanding of FDA’s decision-making process regarding drug applications?
  6. What do you believe would be the potential advantages and disadvantages of posting this information routinely?
  7. Is there any additional information you would like to provide regarding the potential benefits or risks, resource requirements, and international challenges of publicly releasing a limited number of sections from certain CSRs at the time of marketing approval?

Integrated Review Document Questions

To illustrate the new integrated review template, the original reviews for NDA 210806 (PIFELTRO (doravirine) tablets, 100 milligrams (mg)) and NDA 210807 (DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate) tablets, 100/300/300 milligrams) have been rewritten to provide an example. The original multidisciplinary review for the NDAs and the information provided in the new integrated review template are posted on:


  1. How does the new format of the integrated review inform your knowledge of FDA’s basis for making decisions?
  2. How does the usability and accessibility of information in the new integrated review compare to the original review posted on FDA’s website?
  3. How could the information provided in the new integrated review format be used, if at all?
  4. What do you believe would be the potential advantages and disadvantages of posting review documents in this format?
  5. Based on the integrated review, were the issues that concerned the review team clear and understandable? If so, what helped achieve this? If not, what can be improved?
  6. Is there important information in the integrated review that is difficult to locate or should be added?

The new integrated review format is part of a larger modernization of the Office of New Drugs (OND).  The most closely watched aspect of the process is the OND reorganization. The FDA plans to increase the number of offices and divisions to fit a more disease-focused approach. Once the modernization is completed, the agency is hoping assessments OND-wide will be more consistent. As the FDA moves forward, they plan to release other updates to this modernization initiative.

The Agency hopes to receive public feedback on both of these efforts and on how FDA might continue supporting stakeholders’ needs related to the clarity and transparency of drug approval decisions.  Feedback is due August 26th.

Leave a Reply