How much is the FDA user fee?
FY 2021 and FY 2022 User Fee Rates:
| User Fee Type | 2021 | 2022 |
|---|---|---|
| Application Fee – Clinical Data Required | $2,875,842 | $3,117,218 |
| Application Fee – No Clinical Data Required | $1,437,921 | $1,558,609 |
| Program Fee | $336,432 | $369,413 |
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 |
How much is Pdufa fee?
FDA FY2021 user fee table
| FDA User Fee Table FY2021 | ||
|---|---|---|
| Prescription Drug User Fee Act (PDUFA VI) | FY2021 | FY2020 |
| Program fee | $336,432 | $325,424 |
| Generic Drug User Fee Amendments (GDUFA II) | FY2021 | FY2020 |
| Applications: |
How much does an IND application cost?
FY 1993 – FY 2002
| Submission Type | FY 93 | FY 01 |
|---|---|---|
| Drug Applications | ||
| IND | $70 | $200 |
| NDA with Clinical Data – NME | $887 | $1,920 |
| NDA with Clinical Data – Non-NME | $298 | $929 |
What is an example of a user fee?
A user fee is a sum of money paid as a necessary condition to gain access to a particular service or facility. Examples of user fees could include highway tolls or parking garages. People pay user fees for the use of many government-affiliated services and facilities as well.
How have user fees affected the FDA?
The prescription drug user fee reform has led to a substan- tial reduction in new-drug review times. User fee revenues have played a role in improving information technology and staff resources in the fda’s new-drug review division.
Is Aducanumab FDA approved?
On June 7, 2021, the US Food and Drug Administration (FDA) approved aducanumab (Aduhelm; Biogen Inc), the first new drug for the treatment of Alzheimer disease in 2 decades.
What percentage of Pdufas are approved?
In the first few years of the Prescription Drug User Fee Act (PDUFA) program, the first cycle approval rate for new drugs was as low as 23 percent. Now it is about 80 percent on average….
| Brand (Generic Name) | Indication |
|---|---|
| Crestor (Rosuvastatin Calcium) | High cholesterol |
What percentage of Pdufa are approved?
According to the data, 100 percent of all drugs approved in 2019 by CDER met the PDUFA goal date for approval and 58 percent of approved drugs were drugs for orphan diseases….
| Characteristic | Percentage of drugs approved in 2019 |
|---|---|
| Met PDUFA goal date* | 100% |
| First cycle of review | 92% |
Does Pdufa mean FDA approval?
Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA) was first enacted in 1992. PDUFA gives the Food and Drug Administration (FDA) a revenue source, fees paid by pharmaceutical companies seeking the approval of new drugs, to supplement but not replace direct appropriations from Congress.
How long does the approval of an IND application take?
30 days
FOLLOWING RECEIPT OF IND BY THE FDA The IND becomes effective 30 days after the stated FDA receipt date unless the FDA sends notification otherwise. The FDA generally does not send a letter notifying the sponsor-investigator of approval.
How long does it take to get an IND?
An IND application may go into effect: 30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or. on earlier notification by FDA that the clinical investigations in the IND may begin.
Where do I find the FDA user fee?
The appropriate device user fee must be paid for the above listed applications in order for FDA to begin its review, unless the applicant is eligible for a waiver or exemption. Information on user fees is located on the MDUFA user fee page. The applicable fee corresponds with the date the FDA received the submission.
What does human drug application mean under PDUFA?
Under PDUFA, the term human drug application means an application for licensure of certain biological products under section 351 (a) of the Public Health Service Act (PHS Act). What are application fees?
When does FDA reauthorize the prescription drug user fee Act?
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of PDUFA through September 2022. PDUFA VI will provide for the continued timely review of new drug and biologic license applications.
When do human drug application fees need to be paid?
Human drug application fees are due when the application is submitted. Supplements with unpaid fees submitted prior to PDUFA VI will not automatically be considered acceptable for filing once PDUFA VI takes effect in FY 2018. Applicants may submit a new supplement in FY 2018 under PDUFA VI, which will not incur a supplement fee.