How much does an investigational new drug application cost?
How much does an investigational new drug application cost?
Starting in 2022, drugmakers filing new drug applications with clinical data will have to pay the FDA $3.1 million. The FDA’s fee for new drugs with clinical data has risen from a little more than $2 million in 2017 to $3.1 million in 2022.
How much does an FDA application cost?
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 long does an IND application take?
30 days
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.
What is an IND application?
Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place. There are two IND categories: The IND application must contain information in three broad areas:
How do I submit my IND application?
When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever possible ( FDA Study Data Standards Resources ). Each application should be accompanied by: Form 1572 (PDF – 718KB) (Investigator’s statement), and
How many copies of my IND application should I submit?
When submitting original IND applications, sponsors are expected to send their applications in triplicate (one original and two copies). Electronic submissions should be considered whenever possible ( FDA Study Data Standards Resources ). Each application should be accompanied by:
How long does an IND application take to go into effect?
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.
