Top Tips for a Medical Writer to Prepare a Successful NDA
Dr. Nancy Agnes, Head,
Technical Operations, Pepgra
Sales.cro@pepgra.com
In-Brief
Medical writers must be subject matter
experts of the regulatory control inside and
out and know the drug under study in
clinical research. To prepare a successful
NDA(New drug application), a medical
writer should know all the regulatory
submissions basics. Pepgra provides you
with essential tips for a medical writer to
prepare a successful NDA and provides
regulatory writing services.
Keywords: Regulatory writing services,
medical writing services, regulatory
medical writing services, medical writing
companies, medical writing, regulatory
medical writing services, Regulatory
Writing Service in Clinical Research,
regulatory writing, regulatory medical
writing, global regulatory medical writing
services, medical writing solutions, medical
writing in clinical trials, regulatory medical
writing in clinical trials
I. INTRODUCTION
manuscripts and abstracts, essential content
for
healthcare
sites,
health-related
publications or news articles. The scientific
data in these documents need to be
accessible to suit the target audience's level
of understanding, namely, patients or the
general public, physicians or the regulators.
Medical writers require an understanding of
the medical concepts and terminology,
knowledge of relevant guidelines regarding
the structure and contents of authentic
documents, and good writing skills. They
also need to be familiar with searching
medical literature, understanding and
presenting
research
data,
document
reviewing, and editing and publishing
requirements. Many resources are now
accessible for medical writers to regularly
get vital training in medical writing science
and art and regularly upgrade their
knowledge and skills. The demand for the
medical report is growing gradually in
pharmaceutical
and
healthcare
communication
marketplace.
Medical
writers can work individually or active as
full-time professionals.
Medical writing includes writing scientific
documents of different types, with
regulatory and research-related papers,
disease or drug-related and promotional
literature, publication articles like journals,
Copyright © 2021 pepgra. All rights reserved
1
II. TIPS FOR A MEDICAL WRITER TO
PREPARE A SUCCESSFUL NDA
It's never too early to start your NDA
preparation.
It would help if you began to think about
your eventual NDA( New Drug Application)
from the moment you start planning for your
Pre-IND meeting and IND submission, and
well before you have dosed a single patient.
For instance:






about later. You can relax a little better as
the submission date approaches by knowing
what elements can be accomplished early
and then proactively completing those
assignments during medical writing in
clinical trials.
What is the most suitable regulatory
path?
What are clinical trials needed for
the NDA and product label to be
supported?
Do you plan to seek expedited
growth and expedited review?
What is production information
needed for the NDA?
To help your application, do you
need
long-term
toxicology/carcinogenicity studies?
What needs to be outsourced?
All these questions should be front and
centre as early as possible in your mind.
Even though your NDA submission seems
far off shortly, early preparation will make
the difference between smooth sailing and
rough seas.
Start assembling your NDA
Far too often, sponsors wait to start
compiling their NDA until late in
production, which can place undue pressure
on resources and timelines. Note, each piece
of the NDA you can finish and "put on the
shelf" is one bit less that you have to think
Copyright © 2021 pepgra. All rights reserved
In most cases, by the time the drug reaches
the clinic, a significant portion of the
nonclinical program will be completed. All
of this information can be explicitly pulled
into the NDA's related modules and
incorporated as other studies become final.
On the clinical side, as soon as you can, you
should start reviewing your data and
preparing your clinical research reports
(CSRs). Before the research is complete,
you can even start on the report shell. You
can then collect the rest of the components
and collect all the required approval
2
signatures until final data is available.
Analyses have been carried out using
regulatory medical writing in clinical trials.
When the time comes to colonize the NDA
clinical overview pages, completing these
activities
would
also
encourage
performance.
Because of all the data and scientific weight
in the submission, this may seem like a
minor detail. Still, a polished, well-written,
regularly formatted application package that
conforms to current regulatory document
requirements goes a long way to the success
of a submission.
Know the related laws and regulatory
guidelines
Enter your study data
The FDA review division must manage your
application, and for NDAs in general, to
understand the applicable laws and
regulatory guidelines that relate to your
specific program. Although rules are legally
binding, documents of advice are not in
regulatory writing. However, guidance
documents include the regulators' latest
thinking, reviewing the NDA (and hopefully
approve it). Therefore, it should be done
with caution, reason, and consultation with
the FDA's relevant review division to
deviate from these guidelines.
Use standardized templates
When you start writing your IND, make sure
you use uniform models and that a standard
style guide regulates all authorship. To put
together a masterful submission, you don't
have to have a fancy eCTD template kit, but
you can make sure your submission
documents conform to a standard format and
style wherever possible. The same
grammatical,
punctuation,
numbering,
abbreviation, and text conventions should be
practical by all writers working on the
submission and should understand how to
preserve the dignity of the underlying
document's formatting and styles.
Copyright © 2021 pepgra. All rights reserved
To get all your early-phase data entered,
queried, cleaned, and locked, do not wait
until Phase 3. It will save many headaches,
later on, to get an early start on data
management and free up time to emphasis
on other tasks as the NDA submission date
approaches. If the data is locked, you can
start producing study-specific tables,
listings, and figures to help study reports and
summaries inside the NDA.
Request a Pre-NDA meeting
Your primary late-stage opportunity to get
feedback from the FDA on your request is
the Pre-NDA meeting. As such, you must
put a lot of thought into the topics of
discussion you want to raise and ensure that
the questions you pose are straightforward,
well-supported, and placed to allow the
FDA to make a meaningful response.
Suppose any particular elements of your
program or submission may affect
successful filing or review and have not
been
addressed
through
previous
interactions. In that case, it is now time for
the FDA to discuss them. Prepare your
claims and your "Plan B" well in advance
and consider the possible impacts of both of
these on your submission's content and
deadlines from medical writing solutions.
2
Establish realistic timelines for every
aspect
wherever possible, and in close contact with
the publishing team at all times.
Communicate deadlines and obligations, and
follow-up often, to all relevant stakeholders
and participants. The overwhelming amount
of information that needs to be obtained,
processed, interpreted, and shared inside the
NDA should be careful in the timelines.
Establishing an NDA "tracker" is one of the
easiest ways to do this. The most important
thing if the tracker is part of a sophisticated
software package specifically designed for
regulatory
submissions,
a
simple
spreadsheet, must contain some crucial and
actionable submission information. It
requires listing constituent documents with
sufficient granularity, the parties involved,
each document's current status, and the due
dates.
Take the big picture to guarantee a good
submission
Allow at least a month for publishing
your submission
Publishing timelines are often looking at as
something that can be dense if "more
critical" tasks such as authoring or scientific
review take longer than planned. However,
it can sometimes cut to publish timelines,
mainly if study reports and different NDA
parts are being firm up as you go. It is
important not to underrate the vast amount
of effort and time involved in setting up a
proper submission. Even with leading-edge
technologies,
publishing
needs
a
considerable amount of time, not to mention
quality control activities and final validation
of the request, to ensure consistent
document
formatting,
hyperlinking,
bookmarking, and arrangement within the
eCTD system. Publishing timelines should
be compressed with care, prospectively
Copyright © 2021 pepgra. All rights reserved
Take a minute to consider the picture of
what it takes to confirm a good proposal,
whether this is your first NDA or just one of
many that you've done. Pulling an NDA
together is a vast undertaking that takes
considerable time and effort to complete an
investment. Consider your organization or
institution's resources and skills and the
internal ability to execute the necessary
tasks in your desired timelines, and then
make a reasonable assessment of whether
additional support is required.
III. CONCLUSION
Pepgra offers several scalable services to
help our clients yield high-quality,
compliant NDA submissions. Suppose you
are thinking of outsourcing your whole
NDA(New Drug Application). In that case,
you need a partner to assist with publishing
and submitting. Even if you have just one or
two papers that may benefit from an
accomplished clinical pharmacology expert's
examination, Pepgra will help regardless of
your need along with Regulatory Writing
Service in Clinical Research.
REFERENCES
1.
2.
Lies, R. L. (1984). Preparing the Nda Summary: How
to, How Not to and why. Clinical Research Practices
and Drug Regulatory Affairs, 2(3), 259-271.
Schwarz, S. W., Dick, D., VanBrocklin, H. F., &
Hoffman, J. M. (2014). Regulatory requirements for
PET
drug
production. Journal
of
Nuclear
Medicine, 55(7), 1132-1137.
2