UPDATE 12/30/2020:
FDA publishes new OTC drug user fees, read more here.
Original Post 08/27/2020:
FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with the newly established Over-the-Counter Monograph User Fee Program (OMUFA), enacted as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
Fees will be assessed for submitters of OTC Monograph Order Requests (OMORs) and annual facility registration fees from certain manufacturers of OTC monograph drugs. Qualifying contract manufacturing organization (CMO) facilities will pay two-thirds of the amount that non-CMO facilities pay.
These annual fees will be due 45 days after FDA publishes them in the Federal Register. FDA has not yet released the cost of fees associated with OTC drug manufacturing facilities.
Annual Establishment Registration Fees: Medical Devices
All medical device manufacturers and distributors must pay an annual establishment registration fee to FDA. The Device Facility User Fee (DFUF) is $5,546 this year and must be paid between October 1, 2020, and December 31, 2020.
FDA Drug Program Fees
Drug application fees apply to the approval of new drugs or biological products under section 351(a) of the Public Health Service Act. Program fees apply to prescription drug products already approved by the start of the fiscal year. Each year FDA updates Prescription Drug User Fee Act (PDUFA) fees. FDA is also updating fees associated with Generic Drug User Fee Amendments (GDUFA), such as the Abbreviated New Drug Application (ANDA). Many of these fees are recurring and assessed annually. Companies wishing to newly register must also submit payment before FDA will begin its review.
| PDUFA Application requiring clinic data | $2,875,842 |
| PDUFA Application not requiring clinic data | $1,437,921 |
| PDUFA Program fee | $336,432 |
| GDUFA ANDA | $196,868 |
| GDUFA DMF | $69,921 |
| GDUFA Large Program (20+ ANDAs) | $1,542,993 |
| GDUFA Medium Program (6-19 ANDAs) | $617,197 |
| GDUFA Small Program (5 or fewer ANDAs) | $154,299 |
| GDUFA Domestic API Facility | $41,671 |
| GDUFA Foreign API Facility | $56,671 |
| GDUFA Domestic FDF Facility | $184,022 |
| GDUFA Foreign FDF Facility | $199,022 |
| GDUFA Domestic CMO Facility | $61,341 |
| GDUFA Foreign CMO Facility | $76,341 |
| GDUFA Backlog | $17,434 |
| OMOR Tier 1 | $500,000 |
| OMOR Tier 2 | $100,000 |
Manufacturers and distributors failing to pay the relevant fees risk being detained at the border. Don’t let that happen to you. FDAImports can help you navigate this process and ensure you are registered correctly and on time.
