Get the free Biosimilars User Fee Cover Sheet; Form FDA 3792 - gpo

This document is used by manufacturers of biosimilar biological product candidates to submit the necessary information for the assessment and collection of user fees required by the FDA for biosimilar

How to fill out biosimilars user fee cover

How to fill out Biosimilars User Fee Cover Sheet; Form FDA 3792

1. Download Form FDA 3792 from the FDA website.
2. Complete the applicant information section with your name, company, and contact details.
3. Provide the product information, including the product name and approval number.
4. Fill in the fee information, ensuring you select the correct user fee category.
5. Sign and date the form at the designated section.
6. Submit the completed form as part of your application package to the FDA.

Who needs Biosimilars User Fee Cover Sheet; Form FDA 3792?

1. Any individual or entity that is submitting an application for a biosimilar product to the FDA.
2. Companies seeking market approval for biologics that fall under the biosimilar category.
3. Applicants looking to pay the appropriate user fees associated with biosimilar applications.

People Also Ask about

What is the purpose of the user fee?

A user fee is a charge imposed by the government for the primary purpose of covering the cost of providing a service, directly raising funds from the people who benefit from the particular public good or service being provided.

Is PDUFA the same as FDA approval?

To support its public health activities, the FDA relies on (1) annual funding that Congress provides for the agency, and (2) Congressionally-authorized user fees paid by industries that make and market FDA-regulated products, and paid by certain other entities.

What is the biosimilar user fee Act?

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2022 through September 2027.

What is the Pdufa user fee cover sheet?

What is the PDUFA User Fee Cover Sheet? Form FDA 3397, the PDUFA user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to help FDA track payments.

What is the facility user fee?

A user fee is a fee, tax, or impost payment paid to a facility owner or operator by a facility user as a necessary condition for using the facility. People pay user fees for the use of many public services and facilities.

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What is Biosimilars User Fee Cover Sheet; Form FDA 3792?

The Biosimilars User Fee Cover Sheet; Form FDA 3792 is a form that must be submitted to the FDA as part of the biosimilars user fee program, which helps fund the review process of biosimilar applications.

Who is required to file Biosimilars User Fee Cover Sheet; Form FDA 3792?

Any sponsor or applicant submitting a biosimilar application to the FDA is required to file the Biosimilars User Fee Cover Sheet; Form FDA 3792.

How to fill out Biosimilars User Fee Cover Sheet; Form FDA 3792?

To fill out the Biosimilars User Fee Cover Sheet; Form FDA 3792, applicants must provide requested information accurately, including contact details, application type, and fee information as specified in the instructions provided with the form.

What is the purpose of Biosimilars User Fee Cover Sheet; Form FDA 3792?

The purpose of the form is to collect the necessary user fees for the FDA's review of biosimilar applications, ensuring that appropriate funding is available for timely processing and evaluation.

What information must be reported on Biosimilars User Fee Cover Sheet; Form FDA 3792?

The form requires reporting of information such as the name and address of the applicant, the type of application, the drug name, and the user fee amount being submitted.