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7 Tips on How to Write for a Regulatory Reviewer

June 8, 2016 | Jennifer Moen, PhD, RAC, Principal Clinical Research Scientist | Medical Writing Services

Ever tried to write a document and you weren’t sure where to start? The answer is – put yourself in the shoes of your audience and work from that mindset. In our industry, the audience is typically from a regulatory agency (eg, FDA, EMA, PMDA) – and could be a clinical, statistical, or CMC reviewer, among others.

Here are 7 tips on how to write effective documents for review by a regulatory audience.

1. Understand the purpose of your document in the big picture and fulfill that purpose.
I can’t stress this one enough!

There are many stages in drug development, and it’s crucial to understand what role your document plays in the overall picture in order for it to be effective.

What does your reviewer need to know about your study or program to evaluate its success?

For example:

Image courtesy of David Castillo Dominici from
  • Clinical study report – Do your conclusions support the objective of the study?
  • Module 2 summary document – Taken together, what story do the studies in your program tell? Are there any issues that need to be addressed head-on?
  • Briefing document – At a minimum, what data do the Agency need to review in order to answer the questions you’ve asked?

2. Know the regulatory guidance(s) related to your document type.

This one is obvious but can’t be overlooked. If a regulatory authority has issued a guidance related to a particular document type (eg, CSR, briefing package), it behooves you to follow their guidance!

That said, experience with different document types is also important in their creation, given that many guidances are open for interpretation. For example, some believe that the ICH E3 guideline for CSRs is a template – in fact, it is not, it is a guideline.

Multiple exposures to different document types help writers truly understand the “spirit” of each guidance.

3. Provide clear, concise messaging.

Once you’re clear on the overall purpose of your document in the program and the regulatory requirements specific to that document, make sure that the key messages and conclusions are clear for the reviewer.

Indeed, it’s true that reviewers are going to evaluate the data and come to their own conclusions. That said, as regulatory medical writers it is our job to interpret the data and communicate the message in a clear and concise fashion.

[Note that this does not mean we should describe every piece of data! Regulatory reviewers are smart people who do not appreciate pages of descriptive text.]

4. Be consistent.

Make life as easy as possible for your reviewer by providing consistency across your document.

Consistency in messaging, language, and format is important for effective regulatory documents. Agreeing to messages before writing, following a style guide, and using templates are easy ways to ensure such consistency.

Regulatory documents are not the time for creative writing/formatting!


5. Provide sufficient context where needed.

Most reviewers do not read a document from beginning to end. Since a document will likely be reviewed by several disciplines, this means that any given reviewer may begin their review at whichever point in the document is appropriate for their discipline.

With that in mind, consider repeating (or cross-referencing) important information that may be needed for context in multiple places throughout a document. Since too much repetition is not ideal, it’s important to keep your reviewer in mind when making the decision about when to repeat (or cross-reference) information.

6. Make the document easy to navigate.

In this day and age, most reviewers are reviewing electronically. This means that making the document easily navigable is crucial to success.

Some tips include:

  • Use cross-references as necessary to make it easy for your reviewer to find supportive information. (Never make a reviewer go more than 2 clicks for supporting documentation.)
  • Use subheadings as appropriate to make it easy for reviewers to navigate within the document.

7. Write with the end in mind.

What does this mean, you ask? Essentially, this goes full circle to #1.

Most of drug development is leading up to one quintessential document, the product label. Keep the label in mind as you draft all of the messaging in your documents.

If you are ever unclear about what to write in a regulatory document, the best advice I can give is to take a step back and be objective. Put yourself in your reviewers’ shoes and see if your words convey clear, concise messages that support the purpose of your document in your overall development program. If they do, you’re good! If they don’t, you may want to consider revising…

If you follow these tips, I promise you will be on your way to writing effective regulatory documents. But if you need more help, please don’t hesitate to contact us. We have years of experience perfecting the art of writing for regulatory reviewers and we are happy to share what we’ve learned!

Category: Medical Writing Services
Keywords: regulatory medical writing, regulatory review

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