Investigational New Drug Application (IND)

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What Is Drug Application

There are two broad categories of drug applications controlled by the United States Food & Drugs Administration (FDA):

1. Request for authorisation for clinical investigation
2. Request for marketing approval

Investigational New Drug Application comes into the first category of drug application, which we will describe here.

Investigational New Drug Application (IND):

An investigational New Drug Application (IND) is required for approval to begin clinical studies on new drugs in humans. It is an essential document which is necessary for a pharmaceutical firm for getting approval from the U.S FDA. The primary purpose of this application is to ensure the safety, effectiveness and rights of clinical trials in participants.

An investigational New Drug Application is the request from a sponsor for getting permission from FDA to administer an investigational product to humans for clinical investigation after conducting a pre-clinical trial in animals. The sponsor submits the application to FDA or DCGI for conducting a human clinical trial and this application is called Investigation New Drugs Application (IND).

When the IND has been submitted sponsor waits for 30 days for conducting the clinical trial.  When FDA and local institutional review board reviews the IND then the clinical trial can start by the investigator. Institutional Review Board (IRB) reviews the protocol of the clinical trial, the informed consent form of participants and appropriate steps to prevent harm to subjects (Participants). If at any time during the clinical trial if the data provided to the FDA indicates that the investigational product is toxic according to the FDA’s benefit and risk criteria then FDA may stop the clinical trial.

Types Of Investigational New Drugs:

1. Commercial IND: This type of application is submitted by the company to grant marketing approval.
2. Research IND (Non-Commercial ): This application is submitted to permit the sponsor to obtain scientific knowledge of new drugs.
3. Emergency IND: This application is submitted to obtain the permit for an experimental drug in an emergency situation. It does not allow submission of IND in accordance with 21 CFR Sec312.23 or Sec 312.34
4. Investigator IND: It is submitted by the physicians who conduct an investigation and administers the investigational product. A physician can submit this application to propose and study unapproved drugs or an approved drug for a new investigation or in a new patient population.
5. Treatment IND: It is submitted by the sponsor for experimental drugs. It shows promise in clinical testing for serious or life-threatening conditions.

Content Of Investigational New Drugs:

This application contains three information in three broad areas:

1. Animal Pharmacology and Toxicology: An assessment of preclinical data as to whether the product is reasonably safe in humans for initial testing. Any previous experiment with the drugs in humans.
2. Manufacturing Information: Information related to composition, manufacturer, stability and controls used for manufacturing drug products.
3. Clinical Protocol and Investigator Information: Detailed protocol of clinical study to ensure that subjects are not exposed to inappropriate risk. Also, provide information on the qualification of investigators and whether they are fulfilling their medical duties. it must contain informed consent from all research subjects, and obtain a review of the study by IRB, to comply with the IND regulation. It must also include the investigator’s brochure.

Format Of IND:

A) Cover sheet (Form-1571)

• Name, Address, and the telephone of the sponsor.
• Identification of phases
• Commitment by IRB-Form 56
• Commitment to conducting CT accordance in with regulations
• Commitment not to begin CT until IND approval
• Name, title- Monitor
• Name, title-person (s) for reviewing
• Name address of CRO, if any
• Signature of sponsor

B) Table of content

C) Introductory statement & general investigational plan

D) Investigator brochure

E) Study protocol

F) Investigator facilities & IRB data

G) Chemistry manufacturing & control data

H) Pharmacology & Toxicology data

I) Previous human experience

Frequently Asked Question

Que: What phase is an IND submitted
Ans: IND is required for phase-1.

Que: How many digits are in an IND number?
Ans: There should be three digits- serial number. The initial IND number should be 000. Each subsequent submission (e.g Amendment, report or correspondence) is required to be numbered chronologically in sequence.

Que: What happens after IND submission?
Ans: Once the IND is submitted, a drug manufacturer can ship the investigational new drug to the investigator named in the application. An investigator cannot introduce the new drug to participants until the IND application goes into effect.

Que: What is 1572 in a clinical trial?
Ans: It is a form that must be filled by an investigator conducting a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S Food & Drug Administration Code of Federal Regulations for the clinical trial.

Que: How many modules does an IND application contain?
Ans: It has five modules : 1) Region-specific information, 2) Summary document, 3) Quality related information,  4) Non-clinical study reports,  5) Clinical Study Reports

Disclaimer: All the content of this article is for information purposes only.

References: www.fda.gov