We all know that sponsors invest a lot of money in animal and human clinical studies where they test the safety and efficiency of a new drug. Sites are chosen which conduct the trials and in the end, they gather data for further analysis. But, what’s the purpose of it all? What happens after the trials end? After a trial ends, the sponsor determines if it went well enough for him to be able to submit a New Drug Application to the FDA. An NDA is submitted in order for the FDA to approve the new investigational product on the market. So, here we’ll discuss the ways in which the FDA reviews the NDA and ways in which you can increase your chances to get approved.

1. New Drug Application (NDA):
How to Speed Up FDA Approval

2. Introduction
We all know that sponsors invest a lot of money in
animal and human clinical studies where they test the
safety and efficiency of a new drug.
Sites are chosen which conduct the trials and in the end,
they gather data for further analysis. But, what’s the
purpose of it all? What happens after the trials end?
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3. Why are clinical trials conducted? What’s the end purpose?
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To begin, it’s important to understand
that an FDA reviewer can receive
piles of these NDAs (new drug
applications) every month. Out of all
these NDAs, some will be approved
and some will be denied. However, it’s
important to remember that the FDA
and the sponsor have a mutually
beneficial relationship. If there are
fewer sponsors and trials, there is less
work for the FDA reviewers. So, no
reviewer is going to refuse your
application without a valid reason for
it.
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After a trial ends, the sponsor determines if it went well enough for him to
be able to submit a New Drug Application to the FDA. An NDA is
submitted in order for the FDA to approve the new investigational product
on the market. So, here we’ll discuss the ways in which the FDA reviews
the NDA and ways in which you can increase your chances to get
approved.

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TRIAL RESULTS
3 STEP
TRIAL EXECUTION
TRIAL PROBLEMS 2 STEP
1 STEP
What do FDA Reviewers Look For?

5. 5
Trial Execution
As we’ve mentioned before, throughout each trial, data
is gathered with the purpose to be analyzed in the
future and be able to draw a conclusion out of. This
means that when you submit your NDA, the FDA
reviewer is the one who will analyze this data and
decide if it’s worth it. The FDA’s first review area is the
trial execution.

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Trial Execution
What were the initial plans for
the trial execution?
How was the trial actually
executed?
Is the answer to these two
questions the same?
During the reviewing process, they will be looking to find answers to the following questions:

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Trial Execution
What were the initial plans for
the trial execution?
How was the trial actually
executed?
Is the answer to these two
questions the same?
The purpose of these questions is for the reviewer to
estimate how well the trial was executed based on
the initial plans.
For you, as a sponsor, the best way to increase your
chances of being approved and to speed up the whole
process is to provide them with an easy, simple, and
understandable data analysis. Like this, you save the
reviewer’s time and you make it easier for him/her to
reach a conclusion.

8. 8
Trial Problems
One thing that many sponsors fail to understand is that
problems presented in trials can be resolved even
before the submission of the NDA and that they are
able to collaborate with FDA reviewers who will help
them resolve these problems. Problems that occur
throughout the conducting of the trial is one of the most
important focus areas of the FDA.

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Trial Problems
If you’re aware of problems or potential problems in your trial
and you submit your NDA without having these problems
resolved, then the FDA reviewer will spot them and ask you to
resolve them. So, here you again lose time and money and the
whole approval process is slowed down. Instead, it’s best to work
together with reviewers even during the trial and let them help
you to resolve all issues before submitting your application. As
you can imagine, known and settled problems are usually not a
worry. The issue arises with potential problems that the reviewer
can spot. In order to prevent this, it’s essential to spot these
problems before the reviewer can and even before they arise.
Like this, you’ll be able to correct them on time instead of trying
to correct them during the approval process. Collaboration
between sponsors and FDA reviewers is important exactly for this
reason!
Settled &
Resolved
Problems
Already Known
Problems
Potential or
Future
Problems
An FDA reviewer will focus on three main problems:

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Trial Results
The third main focus area of reviewers has to do with
the results of a trial. As we all know, a clinical trial has a
lot of data, so sometimes, it can be difficult for a
reviewer to find out how the results are calculated. In
this chapter, we’ll tell you how to simplify the results of
a trial so that you make the reviewer’s job easier and
speed up the whole process.

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Trial Results
A great way to simplify the reviewer’s job in this area is by
specifying which ways you used to draw your conclusions.
For example, you can try creating an overview page
where you lead the reviewer through your process of data
analysis and conclusions. Like this, he’ll spend less time
trying to figure out the details and this will speed up the
decision-making process. Sponsors spend a lot of money
each day a drug stays with a “review” status, so if the
reviewer sees confusion and irregular data, the process
will be slowed down until you are able to resolve all the
issues he finds in your application. Making the application
as simple and as clear as possible is crucial in this scenario.
Overview Page

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CONCLUSION
As a final note, we would like to remind you again that sponsors and the FDA depend on each other and they should nurture a mutually
beneficial relationship. Next, always keep in mind the needs of the reviewer when you’re preparing your NDA. And finally, make sure
that you don’t forget the reviewer’s 3 main focus points: trial execution, trial results, and trial problems. Having all these things covered
will help you to conduct a good trial and produce better data and results for analysis. Additionally, a well-conducted trial usually has less
delays which means it will be cheaper for the sponsor. As we can see, there are many reasons why a sponsor should always keep good
contacts with FDA reviewers. The better the trial and the fewer problems arising, the more secure and faster the reviewing process will
be, and the sooner the new drug will be on the market. After all, that’s the end goal of every sponsor. Always be proactive and stay on
top of all problems that arise throughout the trial. This proactive approach is the safest way to success.
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