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Prescription Drug User
Fee Act Waivers,
Reductions, and
Refunds for Drug and
Biological Products
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes
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How to fill out prescription drug user fee
How to fill out prescription drug user fee
01
Obtain the necessary prescription drug user fee form from the appropriate regulatory agency.
02
Fill out all required fields on the form, including personal and contact information.
03
Provide information about the prescription drug being submitted for approval, including its name, purpose, and dosage form.
04
Calculate the appropriate fee for the submission based on the regulatory agency's guidelines.
05
Attach any supporting documents or evidence required by the regulatory agency.
06
Double-check the filled-out form and supporting documents for accuracy and completeness.
07
Submit the completed form and fee payment to the designated address or online portal as instructed by the regulatory agency.
08
Keep copies of the filled-out form, supporting documents, and payment receipt for your records.
Who needs prescription drug user fee?
01
Pharmaceutical companies or manufacturers that are seeking approval for new prescription drugs or modifications to existing drugs need to pay the prescription drug user fee.
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What is prescription drug user fee?
Prescription drug user fee is a fee charged by the FDA to drug manufacturers to help fund the review process for new drug applications.
Who is required to file prescription drug user fee?
Drug manufacturers who submit new drug applications to the FDA are required to file prescription drug user fee.
How to fill out prescription drug user fee?
To fill out prescription drug user fee, drug manufacturers need to submit the required forms and payment to the FDA.
What is the purpose of prescription drug user fee?
The purpose of prescription drug user fee is to provide additional funding for the FDA to review new drug applications in a timely manner.
What information must be reported on prescription drug user fee?
Drug manufacturers must report the necessary financial information and payment details on the prescription drug user fee.
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