In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the Center for Drug Evaluation and Research’s (CDER’s) Office of Oncology Diseases (OOD). Providing the Assessment Aid with your NDA/BLA is voluntary. As noted by the FDA, “Applicants who do not wish to participate in the Assessment Aid program will follow the usual submission process with no impact on review timelines or benefit-risk decisions.” However, we believe that participating in this program is beneficial.
The FDA may invite you to participate in this program and provide the Assessment Aid template, or you can request it for any application to be submitted to the OOD. In the past year, we have prepared several Assessment Aid documents for our clients. Below, I outline key processes for participation in this program and our approach for writing an Assessment Aid.
Process and Content
The Assessment Aid is a document template based on the Multidisciplinary Review template and covers the application’s key points. The main objectives of the Assessment Aid are to:
- focus the FDA review on critical thinking
- increase review efficiency and consistency
- decrease review time spent on administrative tasks such as formatting
The Assessment Aid differs from the currently used Multidisciplinary Review document. As noted by the FDA, “Importantly, the new format leads to a more dynamic review process where key regulatory questions can be answered more thoroughly and effectively.”
Each section of the Assessment Aid is clearly delineated to be filled out by either the applicant or the FDA. Certain sections are divided into 3 parts to emphasize the owner of each position:
- data (completed by the applicant) – a concise presentation of the objective results
- applicant’s position – the applicant’s interpretation of the data presented
- FDA’s assessment – the agency’s analysis of the data presented and the applicant’s position
The Assessment Aid should be submitted in Microsoft Word format so that FDA can add their assessment to the same document. The FDA provides examples of completed Assessment Aids on the Oncology Center of Excellence Assessment Aid website (https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid). The Applicant should only include critical information as the total document should be no longer than 100 pages for new molecular entity (NME) applications or 75 pages for supplemental applications. The Assessment Aid is viewed as a standalone document, i.e., no cross-references to locations in the NDA/BLA submission should be included. For example, insert all tables and figures directly into the Assessment Aid. Therefore, the information provided should be concise and self-sufficient.
Timing for Submission of Assessment Aid
An applicant can request to participate in the Assessment Aid program by sending a notification of interest to the division Regulatory Project Manager prior to the submission of the application or at the pre-NDA/BLA meeting. In addition, we have seen the FDA request at the pre-submission meeting that the client consider submitting an Assessment Aid.
The Real-Time Oncology Review (RTOR) pilot program explores a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. For applications being submitted as part of RTOR, the FDA prefers that an Assessment Aid be provided.
The Assessment Aid is typically submitted with the application; however, there are exceptions. For the RTOR program, applicants may submit the Assessment Aid before or at the time of the NDA/BLA submission. At least one of our clients got agreement to submit the Assessment Aid within 30 days following the final module submission.
Our best practices based on our experience with writing Assessment Aids are to:
- Review the Assessment Aid template sections early and evaluate what content is to be provided versus your planned submission content. This review may reveal an inadvertent deficiency in the application that can be addressed before the application is submitted.
- Prepare and gain early internal agreement of an outline that identifies the planned content and source documents (e.g., tables and figures from clinical study reports, CTD summary modules, integrated summaries).
- Pull the data and text directly from the FINAL source documents to ensure consistency, accuracy, and avoid rework.
- Write this as a critical summary of the applicant’s NDA/BLA (or supplement).
- Ensure there is no new information that is not in the application.
- Do not use promotional language.
The Assessment Aid can be a valuable tool in preparing your application. We can guide you through the process and provide experienced writers to create this essential document for your submission. Contact us if you are interested in using the Assessment Aid for your oncology submission.
FDA Oncology Center of Excellence. Assessment Aid. https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid. Accessed 17 March 2021.
FDA Oncology Center of Excellence. Real Time Oncology Review Pilot Program. https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program. Accessed 17 March 2021.