Table of Contents
When should I apply for IND?
The filing deadline is within 60 days of annual date of the IND. If there are multiple protocols under a single IND, each should be identified by title and have a summary report. The investigator should include the status of each study still in progress and each study completed during the previous year.
Do all clinical trials require an IND?
The short answer is that an IND is required for any clinical investigation involving administration of a drug to humans, unless the study is exempt.
What is the purpose of an IND application?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
What is needed for IND application?
The IND application must contain information in three broad areas: Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
Do you need a new IND for each indication?
An IND is required when a drug is involved in a clinical investigation that is not exempt from the regulations. There is no intent to report the investigation to FDA as a well-controlled study in support of a new indication and no intent to use it to support any other significant change in the labeling of the drug.
How long does it take to get IND approval?
The IND must make a decision on your application for review within 6 weeks. The decision period of 6 weeks always starts on the last day on which you are able to submit an application for review. Even if you submit the application for review earlier. This decision period can be extended by a maximum of 6 weeks.
What is the difference between an IND and NDA?
The NDA is a formal request made by a Sponsor to market a new drug in the United States. Data collected during the IND phase of the development program will become part of the NDA. However, the NDA is much more comprehensive than the IND and is expected to provide very detailed information about the drug.
Do you need IND before Phase 1?
An IND submission for Phase 1 studies is required by regulation to contain the sections enumerated below. Clarifications are described when appropriate beneath each section heading.
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.
Do supplements need an IND?
No. When a lawfully marketed botanical dietary supplement is studied for its dietary supplement use (i.e., structure and/or function claims), an IND is not required. Structure and function claims are statements that describe the effect a dietary supplement may have on the structure or function of the human body.
When is an IND required?
To help provide clarity on IND requirements and potential IND exemptions, the FDA has published a guidance document that relays its current thinking on these topics. So, when is an IND required? The short answer is that an IND is required for any clinical investigation involving administration of a drug to humans, unless the study is exempt.
How long does it take for an IND to be approved?
Upon receipt of an IND application, FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter. 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
When is an IND required for clinical trials?
So, when is an IND required? The short answer is that an IND is required for any clinical investigation involving administration of a drug to humans, unless the study is exempt. That seems like a fairly straightforward statement, but there is a lot to consider there.
What are the procedures for submitting an IND application?
IND Application Procedures: Overview. 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: