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Pharmacy|Your 2023 Prescription Drug List Traditional 3Tier Effective September 1, 2023This Prescription Drug List (PDL) is accurate as of September 1, 2023, and is subject to change after this date.
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How to fill out prescription drug user fee

How to fill out prescription drug user fee
01
Determine the appropriate form for the Prescription Drug User Fee based on the type of submission (e.g. New Drug Application, Biologics License Application, etc.)
02
Complete the required fields on the form accurately and thoroughly, including information about the drug product, applicant, and fee payment.
03
Submit the completed form along with the required fee payment to the appropriate address or online portal specified by the FDA.
04
Keep a copy of the submitted form and payment receipt for your records.
05
Await confirmation of receipt and processing of the Prescription Drug User Fee by the FDA.
Who needs prescription drug user fee?
01
Pharmaceutical companies and applicants seeking approval for new prescription drug products from the FDA need to pay the Prescription Drug User Fee.
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What is prescription drug user fee?
The prescription drug user fee is a fee that pharmaceutical companies pay to the FDA during the drug approval process. It helps fund the review and regulation of new drug applications.
Who is required to file prescription drug user fee?
Pharmaceutical companies that are submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) are required to file the prescription drug user fee.
How to fill out prescription drug user fee?
To fill out the prescription drug user fee, companies must complete the appropriate forms provided by the FDA, provide necessary payment information, and submit it along with their drug application.
What is the purpose of prescription drug user fee?
The purpose of the prescription drug user fee is to provide funds that enable the FDA to expedite the review process of new medications and improve the efficiency of drug approval.
What information must be reported on prescription drug user fee?
Companies must report details such as the type of application being submitted, the drug's name, the amount of the fee, and the payer's information on the prescription drug user fee.
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