The Generic Drug User Fee Amendments of 2012 (GDUFA) authorizes the U.S. Food and Drug Administration (FDA) to collect user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. On July 31, 2014, FDA published the fiscal year (FY) 2015 generic drug user fee rates, effective October 1, 2014 through September 30, 2015. The FY 2015 generic drug user fee rates are as follows:
- For each new Abbreviated New Drug Application (ANDA): $58,730
- For each new Prior Approval Supplement (PAS) to an Approved ANDA: $29,370
- One-time fee for Drug Master Files (DMF): $26,720
- Annual fee for Domestic Generic Drug Active Pharmaceutical Ingredient (API) Facilities: $41,926
- Annual fee for Foreign Generic Drug Active Pharmaceutical Ingredient (API) Facilities: $56,926
- Annual fee for Domestic Finished Dosage Form (FDF) Facilities: $247,717
- Annual fee for Foreign Finished Dosage Form (FDF) Facilities: $262,717
User fees are required for all PAS changes requiring approval under FDA regulations, including labeling and microbiology. It is important to ensure PAS changes strictly follow FDA regulations, because FDA only offers a partial refund for refused applications. Registrar Corp’s Drug Labeling and Ingredient Review service can help determine your drug’s likely classification and modify your drug labeling to comply with U.S. FDA regulations.
The DMF fee applies to DMFs that cover the manufacture of an API for use in a generic drug application (Type II). Failure to pay the DMF fee will result in the DMF being unavailable for reference. No generic drug submission referencing the DMF will be received until the fee is paid. Registrar Corp’s Regulatory Specialists can provide guidance as to required elements, formats, and particularities of DMF submissions.
If facility fees are not paid within 20 days of the due date, the facility will be placed on a public arrears list and no new generic drug submissions referencing the facility will be received by FDA until the payment is made. All FDFs and APIs in non-paying facilities will be deemed misbranded, preventing legal import into the U.S. Facilities manufacturing both generic FDFs and APIs must pay both facility fees. Registrar Corp can assist with the proper submission of payment.
is an FDA Consulting Firm that helps companies comply with U.S. FDA Regulations. If you require assistance with generic drug user fees or any other FDA regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: https://www.registrarcorp.com/livehelp.