Fda form 2301-2026

See details

4.2 out of 5

52 votes

The document is a form (FDA 2301) issued by the Department of Health and Human Services, specifically the Food and Drug Administration, for the transmittal of periodic reports and promotional material related to new animal drugs. It outlines the requirements for reporting adverse drug experiences, clinical data, promotional materials, and other relevant information as mandated by 21 CFR 514.80. The form must be completed by applicants or agents and submitted to the FDA, with specific instructions provided for combined reports involving multiple applications.

Here's how it works

01. Edit your form 2301 online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send 2301 form via email, link, or fax. You can also download it, export it or print it out.

How to use or fill out FDA Form 2301 with DocHub

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Click ‘Get Form’ to open FDA Form 2301 in our editor.
Begin by entering the NADA or ANADA number in the first field. If it has fewer than six digits, add leading zeros for proper formatting.
Fill in the applicant's name and the submission date. Ensure that you also specify the due date for the report.
Provide the drug trade name and chemical name in their respective fields.
If applicable, indicate if this is a combined report by listing all relevant NADA numbers.
Select the type of report from the options provided, such as annual or promotional material.
Complete sections regarding adverse drug experiences and clinical data as required, checking 'None' if applicable.
Finally, ensure to fill out your contact information, including email and phone number, before signing off on the form.

Start using our platform today to easily complete FDA Form 2301 online for free!