What is an FDA Industry user fee?
What is an FDA Industry user fee?
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
How much is FDA certification?
The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.
How much does it cost to file an NDA?
FDA Unveils User Fee Rates for FY 2017
| Prescription Drug User Fee Act (PDUFA) | 2017 | 2016 |
|---|---|---|
| New Drug Application Supplement With Clinical Data | $1,019,050 | $1,187,100 |
| NDA Establishment | $512,200 | $585,200 |
| Annual Product Registration | $97,750 | $114,450 |
| Medical Device User Fee Act (MDUFA) [Small Business] | 2017 | 2016 |
What is a public user fee?
A user fee is a fee, tax, or impost payment paid to a facility owner or operator by a facility user as a necessary condition for using the facility. People pay user fees for the use of many public services and facilities. States may charge tolls for driving on highways or impose a fee on those who camp in state parks.
What is a BsUFA date?
Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027. The public meeting will be held on November 2, 2021, from 9 a.m. to 12 p.m. EST via webcast.
How do I get an FDA certificate?
To apply for a certificate of product registration, you will need to prepare the following:
- Application form.
- Valid license to operate from the FDA.
- Product labels. You must provide copies of the product’s labels in all packaging sizes.
- Product documents.
- Certificate of analysis.
- Product sample.
How do medical device companies pay the FDA?
Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions.
How do I pay an FDA user fee online?
The FDA Account Management System requires first-time users to register and is currently not available for all user fee invoices. To pay invoices online for a specific user fee, click on the user fee program link. For additional information regarding payment methods for user fee programs, please refer to FDA User Fee Payment Information.
How do I get a refund from the FDA for fees?
For additional information regarding payment methods for user fee programs, please refer to FDA User Fee Payment Information. Complete Form FDA 3913 (User Fee Payment Refund Request) to request a refund of user fees paid to the FDA as directed by the Food, Drug, and Cosmetic Act (FD&C Act).
How do I transfer FDA fees to another agency?
Complete Form FDA 3914 (User Fee Payment Transfer Request) to request a transfer of user fees paid to the FDA as directed by the Food, Drug, and Cosmetic Act (FD&C Act). Email the completed Form FDA 3913 or Form FDA 3914 to [email protected] or to your FDA Program Manager.
