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Best Practices for Completing FDA Forms

FDA has more than 300 forms to collect and receive information across a wide range of drug development subjects. In the case of electronic Common Technical Document (eCTD) submissions, there is a specific form (based upon submission type) to be completed and included with every eCTD sequence you submit. These fillable PDF forms provide FDA with information about your company, your product, and your application as required by the relevant portions of the Code of Federal Regulations. FDA uses software to read the information populated in these forms and then uses those data to automatically process your eCTD sequences upon receipt. Without the proper fillable PDF form, your eCTD sequence may be rejected by FDA.

The most common forms you will encounter and use are:

  • Form FDA 356h for ANDA, BLA, and NDA submissions;
  • Form FDA 1571 for IND submissions;
  • Form FDA 2252 for submission of annual reports for ANDAs, BLAs, and NDAs; and
  • Form FDA 2253 for submission of advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP).

In this blog, I’ll explain some common mistakes that pharmaceutical companies make with these forms and how to avoid them.

Download the Correct Version

Many sponsors unwittingly use the incorrect version of the form. Using an incorrect version of a form could mean that key information is missing or misplaced, placing your submission at risk of rejection. Unfortunately, copies of these forms live all over the internet, and it’s easy to download an obsolete form.

Take, for example, the Form FDA 1571.  Did you search for it on Google using the term “1571 form”? At the time this post was written, the top result for that search sends you to an obsolete version of the form, even though that result is found on FDA’s website! Other results for that search will take you to the websites of other organizations who have placed a copy of the form online, but then never updated the copy on their site when the official FDA form was updated.

The best way to find the correct form is always to go to FDA’s Forms website to find the current, official version of every FDA form.  In the search bar, enter the number of the form you’re seeking, e.g., 1571, and the page will be filtered to display only the desired form (and, in some cases, the instructions on how to complete that form).  From here, click the hyperlink to download the fillable PDF form.

Confirm You’re Using the Correct Version

In many cases, someone else will give you a copy of the form to complete, or they may provide you with a completed form to include in Module 1 of an eCTD sequence. How can you confirm that you’ve been given the correct version? There are two key pieces of information to check – the Expiration Date found in the header of the form and the Edition Date found in the footer of the form.

It’s always a good sign when the form you have isn’t expired. However, FDA often revises forms without updating their Expiration Dates. So, a valid Expiration Date alone does not ensure you have the right version of the form.

Next, check the Edition Date in the footer of the form. The footer will include the month and year (in the MM/YY format) that this version of the form was released. Compare this date with the Edition Date shown on FDA’s Forms web page.  If the Expiration Date is current and the Edition Dates match, you are using the correct, current version of the form.

Figure 1 shows a side-by-side comparison of the Form FDA 1571 from FDA’s Forms web page and the form found via the Google search.  While the Expiration Dates are the same, the Edition Dates are different.

Figure 1: Examples of the Expiration Date and Edition Date in the Form FDA 1571

Figure 2 shows the Edition Date displayed on the FDA’s Forms web page, confirming that the form on the left in Figure 1 is the version you should be using.

Figure 2: Example of the Edition Date displayed on FDA’s Forms Web Page

Now that you’ve ensured that you are using the correct FDA form, you and your Regulatory Operations team can have peace of mind that you won’t risk potential rejection or delays. Need more help?

Visit our Regulatory Operations page to learn more about our services.

About the author

Sandra Morris
By: Sandra Morris

Sandra Morris is a submission manager at Certara. She is a Regulatory Operations professional with 20+ years’ experience. As a submission publishing expert, Ms. Morris has strong project management, line management, and technical skills.