The Oncology Center of Excellence developed an Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment of the NDA/BLA application (including supplements).
The Assessment Aid is based on the FDA Multidisciplinary Review template. For most portions of the template, the sections are now divided into two parts, clearly delineated to emphasize the ownership of each position:
- The Applicant’s Position;
- The FDA’s Assessment.
The main objectives of the Assessment Aid are to (1) focus the FDA review on critical thinking (assessment) and (2) increase review efficiency and consistency, and decrease review time spent on administrative tasks such as formatting.
The Assessment Aid template is sent to the applicant during the Investigational New Drug (IND) stage. The applicant will add their position once top-line data are received in anticipation of an original or supplemental NDA/BLA submission. The applicant fills in their positions, and submits the document at the time of the NDA/BLA submission. The applicant portion should be concise and only include critical information (e.g., should generally be no longer than 75 pages).
If the applicant participates in the Real-Time Oncology Review (RTOR) program, they may submit the Assessment Aid before or at the time of supplemental NDA/BLA submission. The FDA review team, after conducting their scientific evaluation, will add their assessment to the same document. The FDA’s assessment will focus on whether FDA agrees or not with the applicant’s position, and any additional findings and analyses.
An applicant can communicate interest in participating in this pilot program to the FDA review division by sending a notification of interest to the division Regulatory Project Manager prior to application submission or at the pre-NDA/BLA meeting. Those applicants who do not wish to participate in the Assessment Aid pilot will follow the usual submission process with no impact on review timelines or benefit-risk decisions. The OCE is evaluating the use of the Assessment Aidand seeking input from internal and external stakeholders.
Q1. Can all oncology drug applications use the Assessment Aid? Where can applicants find the Assessment Aid?
Yes, applicants can communicate interest in participating in this pilot program to the corresponding CDER Office of Hematology and Oncology Products review division. The division will send the template to the applicant during the investigational new drug (IND) stage.
Q2. How is the Assessment Aid different than the currently used FDA Multidisciplinary Review document?
The applicant will complete a template, detailing the applicant’s position. The FDA will then provide their own independent assessment in response to the applicant’s position, using this same template. This will create a more efficient and streamlined review process and reduce the administrative burden on FDA reviewers by permitting them to focus on key results and perform critical analyses that may have been omitted by the applicant. Importantly, the new format leads to a more dynamic review process where key regulatory questions can be answered more thoroughly and effectively.
Q3. Will there be a formal analysis of the pilot and how well it is working? If so, when will this analysis be available?
Yes, analysis will be conducted after each CDER Office of Hematology and Oncology Products review division has completed the pilot.
Q4. How long will the pilot last before it becomes routine practice?
There is no definite timeline for the pilot program.