The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2019 fee schedules for the Generic Drug User Fee Amendments (GDUFA) and Medical Device User Fee Amendments (MDUFA). FY 2019 rates for both amendments take effect on October 1, 2018. To keep industry updated on these requirements, Registrar Corp outlines upcoming changes to these fees below.
Fees for Drug Facilities
GDUFA requires user fees from certain types of drug facilities. On October 1, 2018, generic drug facilities are required to pay any applicable facility fees to FDA. Additionally, GDUFA requires fees for new Type II Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) submissions to FDA. You will find a table of these fees below.
Notable Changes to GDUFA in FY 2019
- ANDA Program Fees – In FY 2018, FDA introduced program fees for ANDA holders. These facilities pay a user fee based on the number of approved ANDAs they hold on October 1 of a given year. The FY 2019 ANDA program fees reflect an approximate 17% increase from the previous year.
- Type II DMF Submission Fees – In FY 2018, the fee for a single Type II DMF submission to FDA was $47,829. FY 2019 will see an approximate 15% increase to $55,013.
You can view a comparison between the FY 2018 and FY 2019 GDUFA fees below:
FY 2019 GDUFA Fees
|Active Pharmaceutical Ingredient (API)||$45,367||$60,367||$44,226||$59,226|
|Finished Dosage Form (FDF)||$211,087||$226,087||$211,305||$226,305|
|Contract Manufacturing Organization (CMO)||$70,362||$85,362||$70,435||$85,435|
|ANDA Program Fees – Based upon the number of approved ANDAs held|
|Large (20 or more ANDAs)||$1,590,792||$1,862,167|
|Medium (6 – 19 ANDAs)||$636,317||$744,867|
|Small (5 or fewer ANDAs)||$159,079||$186,217|
|Type II DMF||$47,829||$55,013|
Fees for Medical Device Establishments
MDUFA requires all FDA-registered establishments to pay a user fee during their annual registration renewal. The FY 2019 establishment registration fee for all establishments is $4,884. According to the publication of MDUFA fees, FDA does not recognize an establishment as legally registered until this fee is paid.
Additionally, MDUFA requires fees for the submission of certain medical device applications to FDA. Small businesses, defined by MDUFA as having gross sales or receipts of no more than $100 million during the most recent tax year, may qualify for discounts to application fees. All medical device application fees reflect an approximate 3-4% increase from the previous year.
You can view a comparison between the FY 2018 and FY 2019 MDUFA fees below:
FY 2019 MDUFA Fees
|Annual Establishment Registration||$4,624||$4,884|
|Application Fees||Standard||Small Business||Standard||Small Business|
|De Novo Classification||$93,229||$23,307||$96,644||$24,161|
|PMA, PDP, PMR, BLA||$310,764||$77,691||$322,147||$80,537|
|BLA efficacy supplement||$310,764||$77,691||$322,147||$80,537|
|PMA annual report||$10,877||$2,719||$11,275||$2,819|
Not sure which fees you may be subject to? Registrar Corp’s Regulatory Specialists can help determine your applicable fees and facilitate payment with FDA. Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.