Art of Searching for FDA Forms for Regulatory Professionals
Regulatory Professionals need to work with FDA Forms on a daily basis whether they are dealing with an Investigational New Drug Application (IND) or New Drug Application (NDA) or Biologics License Application (BLA) or Abbreviated New Drug Applications (ANDA) or any device clearance applications.
Our general instinct is to search for an FDA form on google. But sometimes google tend to show an outdated form. For example, my search for Form 1572 yielded the below form which is no longer current (See red highlight in the below image).
The best way to get access to FDA forms is to directly download them from FDA website. Following steps will guide you through the process.
Step 1: Browse or go to https://www.fda.gov/about-fda/reports-manuals-forms/forms
You can either bookmark this website or alternately search on google for “FDA Forms” and it will take you to above website.
Step 2: In the search bar, type in the form you are looking for.
For example, If I am looking for form 1572, then I type 1572. This search yields two documents. One is the actual form and the other is the instruction or guidance on how to fill the form 1572.
Step 3: Download the actual form.
In this case it is “FDA-1572_R7_Sec_03–30–2022.pdf1.12 MB”. Move your browser to the Form number field associated with actual PDF and click on it (see image below). Form is automatically downloaded on to the computer.
You can now save it to wherever you want on your computer. I strongly recommend downloading the instruction document and use it to fill the corresponding form until you get into the routine of completing the forms.
Note: You also notice a column showing the edition date. This is also the date you see on top right corner of the form once you open the form(see first image). Sometimes edition date could be in the past. For example if you search for 1571 form, the edition date is 03/2019. It does not mean that the Form is invalid or expired. As long as you are downloading it from FDA website, the form is valid. In case if you are habituated to use google to download forms, I strongly suggest you to cross check the edition date of that particular Form from FDA website.
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