How Assessment Aids Can Help You Get Your Oncology Product Approved Faster
- Jayshwini Sanghani
- Jun 3
- 5 min read
A guide for applicants who want to participate in the voluntary program developed by the FDA's Oncology Center of Excellence
Are you looking to bring your oncology drug to market?
If so, you’re probably familiar with the complexity and slow pace of cancer drug approvals. With regulatory approval rates for oncology drugs increasing to just 7.57% [1], it's essential for biotech companies to ensure that every aspect of their submission is robust and well-executed. One way to support this is by including an optional but valuable document called an Assessment Aid (AAid) with your New Drug Application (NDA) or Biologics License Application (BLA).
The AAid is designed to support the FDA’s review process by making your submission easier and faster to understand. When written well, it can help accelerate review timelines and increase your chances of approval. Whether you're a regulatory affairs professional or a medical writer supporting oncology submissions, here’s your practical guide to what it is, why it matters, and how to get it right.
What is an AAid?
An AAid is a voluntary addition submitted along with an NDA or a 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 AAid?
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, which speeds up the review of oncology drugs. Through this program, applicants can submit their data before or at the time of NDA/BLA submission.
Applicants interested in using the AAid should communicate with the FDA review division 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 AAid
The AAid is typically written by the applicant (pharmaceutical or biotech company) and submitted in Microsoft Word format along with their NDA or BLA. 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, 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 include complementary tables and figures directly in the document, not just cross-references. Applicants should provide the names of the datasets used to derive the information presented in the tables.
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.
What are the benefits of using an AAid?
Using an AAid can have several benefits for you and your oncology product. Here are some of them:
Faster review process
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
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
You'll 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 AAid?
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 an 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.
How Morula Health can help
Hiring a medical writer with specific expertise is indispensable for writing an AAid. At Morula Health, we have a global team of writers with experience across different therapy areas and document types. Each writer brings years of experience in clinical settings and medical writing, offering a wealth of knowledge and insight to your project.
Our writers are well-versed in both regulatory guidelines and complex therapy areas like oncology. They’re skilled in preparing NDA/BLA submissions and can handle both your main submission and the AAid, ensuring consistency, compliance, and a streamlined process from end to end.
More information about Assessment Aids
The FDA's Oncology Center of Excellence website provides more information about the AAid, including the template, frequently asked questions, and 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.