Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

As shown in the table below, there were 5 sponsors who participated (and received approval) in the pilot program in 2018, the first year of implementation. The total number of FDA oncology approvals that included an Assessment Aid increased 4-fold in 2019 and then doubled in 2020. Since 2020, approximately 40 applications/year have been approved that included an Assessment Aid.

Note: This table only includes applications for which the drug was approved; it does not account for applications that were filed and have not received approval.

The Assessment Aid is a general template that includes sections for nonclinical data and clinical pharmacology, efficacy, and safety data. If there is no new information to provide, (e.g., a supplemental application with no new nonclinical or clinical pharmacology data), then those sections can state “No new information is provided in the current submission.”

Most sections of the template include the following subsections:

• a data portion to be completed by the applicant (e.g., tables and figures)
• the applicant’s position, which is to be completed by the sponsor and provides their interpretation of the data
• the FDA’s assessment, which is to be completed by FDA and includes their analysis of the data and applicant’s position

An Assessment Aid should be written concisely and only include critical information as there are page limitations (i.e., total document should be no longer than 100 pages for initial applications or 75 pages for supplemental applications). FDA also clearly states that “promotional language should be avoided.”

The information provided in an Assessment Aid should be self-sufficient; it should not refer to sections of the application for further information, and all applicable key tables and figures should be placed directly in the document template. In addition, there should be no new data that is only presented in the Assessment Aid; all content should come from existing sources (clinical study reports, CTD summary modules, integrated summaries) in the application.

Certara regulatory writing collaborates with multiple sponsors each year to provide Assessment Aids as part of their FDA oncology applications. Our recommended best practices for preparing an Assessment Aid are as follows:

• Request the most recent version of the template close to the time of submission (e.g., at the pre-NDA/BLA meeting) as it is a dynamic template that you want to ensure you have the most recent version of.
• Review the template sections 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).
• Use final (content approved), QCed source documents to populate to ensure consistency and accuracy. This will avoid rework and also streamline the review process as there is little/no unapproved content that reviewers have not seen. Also, since the document is submitted in a Microsoft Word format (i.e., not published) so FDA can add their analysis into the document, it can be one of the last documents written and finalized and placed in the submission package (i.e., just days before the submission).

The FDA Assessment Aid can streamline oncology NDA and BLA reviews, improve regulatory clarity, and support Real-Time Oncology Review and Priority Review pathways. However, successful implementation requires strategic planning, disciplined execution, and experienced regulatory writing expertise.

Certara’s global regulatory writing and submissions team supports sponsors across the full lifecycle of oncology applications, including Assessment Aids, NDA and BLA submissions, eCTD publishing, and regulatory operations.

If you are preparing an oncology submission and considering participation in the Assessment Aid program, our experts can help you plan, draft, and integrate this document seamlessly into your regulatory strategy.