USFDA’s Overview: Drug Development Tool (DDT) Qualification Programs

Sharan Murugan
7 minutes ago
3 min read

Developing a new drug is a long, expensive, and complex process. To make drug development more efficient and scientifically robust, the U.S. Food and Drug Administration (FDA) encourages the use of Drug Development Tools (DDTs). These tools help sponsors generate better data, make informed decisions, and reduce uncertainty during drug development.

To support this, FDA has established formal Drug Development Tool Qualification Programs, described on the FDA website Drug Development Tool (DDT) Qualification Programs. These programs allow certain tools to be reviewed and officially accepted by FDA for a defined use in drug development.

A Drug Development Tool is a method, instrument, or model that helps developers measure, predict, or evaluate how a drug works, how safe it is, or how effective it may be. Instead of being used to treat patients directly, DDTs are used to support decisions during drug development.

FDA recognises three main types of DDTs:

Biomarkers, which are biological measurements (such as lab values or imaging results) that indicate normal or disease processes or responses to treatment.
Clinical Outcome Assessments (COAs), which measure how a patient feels, functions, or survives, often through questionnaires or performance tests.
Animal Models for Efficacy (AMMs), which are animal models used to study how a drug might work when human trials are not feasible.

A DDT becomes especially valuable when FDA formally agrees that it is reliable and appropriate for a specific purpose.

Qualification means that FDA has reviewed a DDT and agreed that it can be used for a specific context of use across multiple drug development programs.

In simple words:

Once a DDT is qualified, any sponsor can use it for the approved purpose.
Sponsors do not need to re-justify the tool each time they use it.
Qualification applies only to the defined context of use, not to every possible situation.

FDA explains this concept in detail in the guidance Qualification Process for Drug Development Tools: Guidance for Industry and FDA Staff. Types of FDA DDT Qualification Programs

FDA operates separate qualification programs for different types of DDTs:

Biomarker Qualification Program (BQP)
Clinical Outcome Assessment (COA) Qualification Program
Animal Model Qualification Program (AMQP)

Although the tools differ, the qualification process follows the same overall structure for all programs.

Step-by-Step: How the DDT Qualification Process Works

FDA’s qualification process is stepwise and interactive, allowing early feedback before large investments are made.

Step 1: Letter of Intent (LOI)

This is a short proposal explaining:

What the tool is
Why it is useful
What the proposed context of use is

FDA reviews the LOI to decide whether the tool is suitable to enter the qualification program.

Step 2: Qualification Plan (QP)

If the LOI is accepted, the developer submits a Qualification Plan. This document explains:

What studies will be conducted
What data will be generated
How the tool will be validated

FDA provides feedback to ensure the plan is scientifically sound.

Step 3: Full Qualification Package (FQP)

This is the final submission containing all supporting data. FDA evaluates whether the evidence is sufficient to support qualification for the proposed context of use.

If FDA agrees, the tool becomes qualified and is publicly listed.

Using the FDA DDT Portal

FDA provides a dedicated online platform for DDT interactions called the DDT Qualification Portal. Once qualified:

FDA publishes the qualification decision
The tool becomes available for broad industry use
Sponsors can reference the qualified tool in regulatory submissions without re-validation

However, FDA may revise or withdraw qualification if new data show that the tool no longer performs as expected.

This blog is based on the following FDA resources:

For more information, please refer directly to these FDA webpages and guidance documents.