Regulatory Approval Process For Investigational New Drug (IND)

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Regulatory Approval Process For
Investigational New Drug (IND)

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Investigational New Drug Application (INDA)

It is an application filed to FDA prior to human testing .It gives a full description of chemistry, manufacturing and
controls, pharmacology and toxicology information, any previous human experience.

Types of IND

• An Investigator IND: It is submitted by a physician who both initiates and conducts an investigation and under
whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research
IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient
population.

• Emergency Use IND: This allows the FDA to authorize use of an experimental drug in an emergency situation that
does not allow time for submission of an IND.

• Treatment IND: It 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

• The IND application must contain information in three broad areas:
(1) Animal Pharmacology and Toxicology Studies
(2) Manufacturing Information and
(3) Clinical Protocols and Investigator information.

• Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this
time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to
unreasonable risk.

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IND Content and Format

The requirements for the content and format of IND application are given in the 21 Code of Federal Regulations
(CFR), Section 312. A sponsor (commercial organization) or an investigator who intends to conduct a clinical
investigation should submit an “Investigational New Drug Application” in the following order:

1. Required Forms:

a) Form FDA 1571 Investigational New Drug Application
b) Form FDA 1572 Statement of Investigator
c) Form FDA 3674 Certification of Compliance

2. Table of contents
3. Introductory statement and investigational plan
4. Investigator’s brochure
5. Protocols
6. Chemistry, manufacturing and control (CMC) information
7. Pharmacology and toxicology information
8. Previous human experience
9. Additional information.

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SUBMISSION INFORMATION

• After all the needed information has been acquired, the IND is ready for submission to the FDA.
• Even though the FDA is moving toward requiring electronic submission of an IND in the electronic common technical

document format, paper submissions are acceptable.
• Sponsor-investigators who wish to submit INDs electronically to CDER can submit the documents in portable document

format and any data in statistical analysis system transport files either by email to the review division project manager or
on a CD accompanying the paper copies.

• Sponsor-investigators who wish to submit INDs electronically to CBER should refer to the guidance for industry
Providing Regulatory Submissions to CBER in Electronic Format -Investigational New Drug Applications (INDs) and/or
should contact the appropriate review division in CBER to determine the procedures for submitting INDs to CBER in
electronic format.

• Paper submissions of the initial IND and each subsequent amendment must be provided in triplicate (the original and
two photocopies are acceptable).

• Each submission related to an IND is required to be numbered serially using a single, three-digit serial number. The
initial IND should be numbered “000”; each subsequent submission (e.g., amendment, report, or correspondence) is
required to be numbered chronologically in sequence.

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THE IND APPROVAL PROCESS AND REVIEW PROCEDURES

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THE IND APPROVAL PROCESS AND REVIEW PROCEDURES

• After the FDA receives the IND, an IND Acknowledgement Letter will be sent to the sponsor- investigator.
Once the IND is stamped as received ,it is sent to the review division within CDER. On arrival at the review
division , it is critically evaluated by several reviewers of :

➢ Chemisty
➢ Biopharmaceutics
➢ Medical
➢ Stastistics
➢ Microbiology
➢ Pharmacology /toxicology sections
• All these areas review the data submitted with the primary purpose to ensure safety of the individual enrolled

in the study.
• Once an IND is submitted, the study can’t be initiated until a period of 30 days.
• If there are any major issues relating to the safety of the volunteers in the proposed study , the FDA can

institute a clinical hold.

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INDA ANNUAL REPORTS

• Sponsors should submit an annual report that provides the FDA with a brief update on the progress of all
investigations included in the IND.

• It should contain the following:
➢ Individual study information.
➢ A narrative or tabular summary showing the most frequent and most serious adverse events by body system.
➢ A summary of all IND safety reports submitted during the previous year.
➢ A list of subjects who dropped out because of adverse events and a description of the adverse events.
➢ New information regarding the investigational drug’s actions (e.g., dose response), completed nonclinical

studies, and any CMC changes, if available.
➢ A general investigational plan for the coming year, significant foreign marketing developments.

❖ Canada’s systems for regulating drug products are very similar to those in the United States. At the federal
level, the Therapeutic Products Directorate, an agency of Health Canada that regulates Canada’s drug supply, is
Canada’s counterpart to the FDA. All drug products sold in Canada must be approved by the Therapeutic
Products Directorate. Pharmacies in Canada are regulated by the provinces; a similar system to the U.S. in
which states regulate pharmacies.

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References :

1. New drug approval procedure in different countries: A Review Preeti maan singh*, shilpa pahwa, Sheetl
chaudhary & vandana arora sethi:International Journal of ChemTech Research

2. Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators Guidance for
Industry.

3. Rajkumar V* et al., Regulatory aspects on new drug approval process in usa

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