Close this search box.


Understanding New Drug Application (NDA) and How to Submit One

A Guide to the New Drug Application Process

Since 1938, every new drug of a pharmaceutical company has been the subject of an approved NDA before U.S. commercialization. However, you must be careful when making a new drug application, as it requires specific information.

If this is your first time submitting an NDA, you might wonder how NDAs work and how to complete the drug application process. Otherwise, you could hit a roadblock when creating a new drug.

Therefore, if you’re seeking drug approval for a new substance and want to learn more about NDA, keep reading this article. We’re going to cover the following in the following sections:

• Why Are NDAs Necessary?
• Tips for Applying for an NDA
• Products Under a New Drug Application
• Submitting a New Drug Application
• Benefits of the NDA
• Where to Look for New Drug Application Assistance

Are NDAs Essential?

A new drug application is the only way to get the FDA to approve a drug. The purpose of an NDA is to outline the process of creating a drug, its contents, and all the aspects of production.


This document is vital as it validates a drug and makes it safe for use. Otherwise, it can’t be sold in America, and the label will not be accurate.

After the application is complete, the information is in the Code of Regulations (CFR) for transparency.

Tips for Applying for an NDA

The first tip for applying for an NDA is to plan well in advance. Several drug application categories might require slightly different information, so you need to do research beforehand.

For example, you need to look for requirements like what clinical studies need to be conducted and what manufacturing data is necessary for production.

But it’s also important to consider what jobs can be done in-house and what can be outsourced for better efficiency.

Plus, you will also need to look up the relevant state guidelines that apply to your application. This will save you time and keep you from running into problems later on.

You should also prepare the NDA early to avoid missing guidelines and follow the given template so that all the information is placed in the right spots.

When you’re filling out the application, it’s good to keep note of the information.

For instance, you can create a database on your desktop to ensure you have a reference for all the details you’ve written in the application. That way, your product is transparent and matches up with your records.

What to Include in an NDA

It can be easy to feel overwhelmed when you look at the criteria for an NDA, so it’s important to fill out every section carefully. Let’s break it down into two sections to make it simple and easy to digest.

The first group of information is premarket criteria. In this section, you’ll need to include the maintenance of an IND (Investigational New Drug) and the Pediatric Research Equity Act (PREA).

You’ll also need to include a Prescription Drug User Fee Act (PDUFA) and all the necessary requirements for advertising and labeling the final product.
The next section includes the main NDA pages.

You must provide extensive and accurate information in the NDA section indicating that the drug is safe for use, that risks have been monitored, potential advertising materials have been evaluated, and that careful manufacturing methods have been used.

Once all of these sections are filled in correctly, the FDA can confidently approve a new drug and have it administered for sale.

Products Under a New Drug Application

In general, all non-device drugs require an NDA, meaning hundreds of applications every year. So, to make it easier, here is a list of the products under a new drug application:

• Biologics License Application (BLA)
• Over-the-Counter (OTC) Drugs
• Abbreviated New Drug Application (ANDA)
• Investigational New Drug (IND)
Therefore, if your drug falls into one of these categories, you’ll need to submit an NDA as soon as possible.

Submitting a New Drug Application

When you submit an NDA, you must put it in a common technical document (CTD) format, or it won’t be accepted as a valid application. You must go through this process when submitting a new drug application.

Benefits of the NDA

The main benefit of an NDA is that it allows your new drug to have legal approval by the government and the FDA.

Unless you have this official paperwork, you can’t legally sell a drug or the contents written on the label. Depending on the drug, this means that people could miss out on the benefits of a new drug.

Plus, you can ensure that all your research and evidence are accurate and have the approval of professionals with expert knowledge. So, you don’t need to be concerned about presenting false information.

The only way to release a new drug confidently and legally is to submit it via an NDA to the FDA.

Where to Look for New Drug Application Assistance

Whether you’re new to submitting an NDA or it’s been a while since you’ve been through the process, it’s essential to reach out for help.

Our product, Pristima XD, is a preclinical lab solution that is designed to assist you with research and development. You can book a demo with our team and try it for yourself!

This software enables you to monitor the lab process and helps you manage business tasks while creating a new drug.

And it’s easy to use, so you don’t need to be a professional.

The average NDA takes 10 months. If you have any questions in the meantime, we can help.

Be Prepared for an NDA

Now that you have these tips for submitting a new drug application, you’ll be prepared for the process and know what to expect. But our product is an excellent way to upgrade your pharmaceutical lab system so your drug is ready for approval.

You can use Pristima XD for handling requests, processing, tracking samples, reporting, and other aspects of making and advertising a new drug.

Let us know if you have any further questions about the NDA process. And in the meantime, book a demo and gain better control over your lab process so you can upgrade your production methods.


Ready to learn more? Book a demo with us!