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  • Jayshwini Sanghani

How Assessment Aids Can Help You Get Your Oncology Product Approved Faster

A guide for applicants who want to participate in the voluntary program developed by the FDA's Oncology Center of Excellence


What is an Assessment Aid?


If you are developing a new drug or biologic for treating cancer, you may have heard of an optional document that you can submit to the FDA along with your application. This document is called an Assessment Aid (AAid).


Applicants can submit an AAid along with their New Drug Application (NDA) or Biologics License Application (BLA). It’s based on the FDA Multidisciplinary Review template and aims to facilitate the FDA's assessment of the application by providing a concise and structured summary of the key data and the applicant's position. The AAid also allows the FDA to add their own assessment to the same document, creating a more efficient and streamlined review process.


Who can use an Assessment Aid?


The AAid is a voluntary program that is open to all applicants who are developing oncology drugs or biologics. It can be used for both original and supplemental applications, meaning that you can use it for a new product or for a new indication or formulation of an existing product, as well as for applications that are part of the Real-Time Oncology Review (RTOR) pilot program. Applicants who are interested in using the AAid should communicate with the FDA review division before or at the time of application submission. The AAid is especially useful for applications that involve complex or novel data analyses, endpoints, or study designs, as it can help you explain your rationale and evidence more clearly.


Content of an Assessment Aid


The AAid is typically written by the applicant (pharmaceutical or biotech company) and submitted in Microsoft Word format along with their New Drug Application (NDA) or Biologics License Application (BLA) for oncology products. The AAid has a generic structure that divides certain sections into three parts:


Completed by the applicant:


Data – presents objective results of your clinical trials and other studies (annotated with references to the detailed information in your submission).

Your position – provides your interpretation of the data and your rationale for the approval of your product.


Completed by the FDA:


FDA’s assessment - provides the FDA’s analysis of the data and your position, and states whether the FDA agrees or not with you, and any additional findings and analyses.


The AAid should be concise and self-sufficient, meaning that it should not contain any information that is not included in your NDA/BLA submission and that it should not require any additional documents or sources to understand your data and position. The AAid should also avoid promotional language and use U.S. English and the FDA’s suggested abbreviations throughout the document. You should define acronyms/terms that are not widely known in the oncology field and use consistent terminology and nomenclature throughout the document. The AAid should be no longer than 100 pages for new molecular entity (NME) applications, or 75 pages for supplemental applications. For a guide on what is included in an AAid document, please refer to the document below.


Assessment Aid Table of Contents
.pdf
Download PDF • 100KB

What are the benefits of using an Assessment Aid?


Using an AAid can have several benefits for you and your oncology product. Here are some of them:


Faster review process


By submitting an AAid, you can help the FDA review your application faster, as they will have a clear and organized summary of your data and position, and they will be able to add their own assessment to the same document. This can reduce the need for multiple rounds of communication and clarification between you and the FDA and save time and resources for both parties.


Higher chance of approval


By submitting an AAid, you can also increase the likelihood of getting your product approved by the FDA, as you will be able to present your data and arguments more persuasively and coherently and address any potential questions or concerns that the FDA may have. The AAid can also help you demonstrate the value and benefit of your product for patients and the oncology field.


More transparency and collaboration


By submitting an AAid, you can also foster a more transparent and collaborative relationship with the FDA, as you will be able to see their assessment of your data and position and understand their reasoning and feedback. This can help you align your expectations and goals with the FDA and improve your communication and trust with them.


How can medical writers help with an Assessment Aid?


Writing an AAid can be a challenging and time-consuming task, as it requires a high level of scientific and regulatory expertise, as well as writing and formatting skills. That's why having a professional medical writer can be a valuable asset in the process of writing an AAid. A medical writer can help you with the following aspects:


Clear Communication


A medical writer can help you communicate your complex scientific data clearly and succinctly, using appropriate language and terminology. A well-written AAid can help you convey your message and position more effectively to the FDA and increase your chances of receiving approval.


Document Management


A medical writer can help you manage your document and ensure that it adheres to the specified length and format requirements. They can also help you maintain consistency across your documents, as they can handle both your NDA/BLA submission and your AAid, and make sure that there is no discrepancy or contradiction between them.


Expertise in Regulatory Guidelines


A medical writer can help you comply with the regulatory guidelines and standards that apply to your oncology product and your AAid. They can also help you follow the best practices and recommendations from the FDA and avoid any potential pitfalls or errors that could delay your approval.


More information about Assessment Aids


The FDA's Oncology Center of Excellence website provides more information about the AAid, including the template, the frequently asked questions, and the examples of completed AAids for original and supplemental applications.


Applicants can also contact the FDA review division for further guidance and clarification on how to use the AAid for their specific oncology drug application.


Remember, the decision to write an AAid should be carefully considered, taking into account the company’s resources, the complexity of the drug application, and the potential benefits of the process.


How Morula Health can help


A medical writer with expertise specific to your program can be a valuable asset in the process of writing an AAid. Our medical writers are highly skilled in preparing NDA/BLA submissions. You could benefit from having one medical writing partner handle your NDA/BLA, as well as your additional AAid document. Having the same team of writers creates a streamlined process and guarantees consistency across all your documents.


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