FORM FDA 3911 Instructional Supplement. Instructions for Completion of Form FDA 3911Drug Notification - fda-2025

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The document provides detailed instructions for completing Form FDA 3911, which is used to notify the FDA about illegitimate drugs or those with a high risk of illegitimacy. It outlines the types of reports (initial, follow-up, termination), necessary product information (name, ingredients, classification), and company details required for submission. The form aims to ensure proper communication and tracking of drug safety issues.

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Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is the format of FDA application number?

A pre-assigned application number is a unique six-digit number, e.g., 012345, assigned to sponsors to enable them to identify their application. The FDA requires that you use this number any time you submit an eCTD application.

How many digits is an FDA registration number?

After the U.S. Agent has accepted their designation and once this information is submitted, reviewed, and accepted by FDA, you will then be given an 11-digit food facility registration number and are one step closer to distributing products throughout the United States.

What is the format of FDA NDC number?

Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. Converting National Drug Code (NDC) from a 10-digit to an 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.

What is the FDA application number?

This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. In Drugs@FDA, you can find the NDA number under the column named FDA Application.

What is the FDA form for illegitimate product?

Using Form FDA 3911, the trading partner provides information about: The person or entity initiating the notification. The product that is determined to have a high risk of illegitimacy. A description of the circumstances surrounding the event that prompted the notification.