The document outlines the content and format requirements for submitting an Investigational New Drug (IND) application to the FDA, including necessary components such as the cover sheet, investigational plan, and safety information. It emphasizes the importance of a signed FDA Form 1571 and the correct formatting for application numbers, along with detailed information about the investigational drug's chemistry, pharmacology, protocol, and prior human experience. Additional considerations include information on drug dependence, abuse potential, and the use of devices in conjunction with the IND.

1. IND CONTENT & FORMAT OF AN
IND APPLICATION
SANDESH KU. PATTANAIK
Regd.No.-12001898

2. • Cover sheet (FORM FDA 1571)
• Table of contents
• Introductory statement and a general investigational plan
• Investigators brochure
• Protocols
• Chemistry , manufacturing and control information
• Pharmacology and Toxicology information
• Previous human experience with the investigational drug
• Other Important Information
• Relevant Information

3. Cover sheet (FORM FDA 1571)
• A signed Form FDA 1571 is required for the submission of an IND to the FDA.
• Sponsors should complete the form, but not modify the security settings or make
other changes to the form since the approved, secured, posted form has been
tested and allows for automated processing of submissions to the Center for
Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER).
• all information is present and correct.
• application number is present and correct
• Provide the IND number if it was previously assigned. If an IND number has not
been assigned, leave the field blank.
• For IND numbers less than six digits, the IND number should be preceded using
zeros (i.e., for IND 12345enter 012345).
• For name(s) of drug (21 CFR 312.23(a)(1)(i)),list the generic name(s) and trade
name
• Provide the dosage form, the unique ingredient identifier term and code for
active substances

4. Table of contents
• A sponsor-investigator is required to provide a table of contents and should
provide pagination and tabbed breaks between sections to allow FDA
reviewers to more easily navigate the submission.

5. Introductory statement and a
general investigational plan
• The introductory statement must include the investigational drug’s name and
all of its active ingredients, pharmacologic class, structural formula (if known),
formulation of the dosage form to be used, the route of administration, and the
broad objectives of the proposed clinical trial. There also must be a brief
summary of previous human experience with the investigational drug including
any investigational and marketing experience in other countries.
• The general investigational plan must be summarize the
1. rationale supporting the proposed clinical trial
2. Purpose of the study
3. Indication to be studied
4. Types of trials to be initiated
5. Number of study subjects
6. Risks involved

6. Investigators brochure
• The purpose of the investigator’s brochure is to make particularly vital
information regarding the investigational drug available to the other
investigators involved, who may be located at different geographic locations
• A summary of the chemical, toxicological, and pharmacokinetic aspects of an
investigational drug including any information on its safety and efficacy
obtained from any prior clinical trials, and a description of any anticipated
risks, side effects, precautions, and special monitoring.

7. • It describes the objective of the study
• the trial design
• how subjects would be selected
• how the trail is to be conducted.
Protocols

8. Chemistry , manufacturing and control
information
• Determines the adequacy of methods used to
• manufacture and assay investigational
• compound
• Safety concerns
• Describe drug substances
• Method of preparation
• Reagent and solvents
• Acceptable limits and analytical methods
• ensure quality and purity of drug.

9. Pharmacology and Toxicology
information
• The sponsor-investigator must provide adequate information about the
pharmacological and toxicological studies of the investigational drug
involving lab animals or in vitro to support the sponsor-investigator’s
conclusion that it is reasonably safe to conduct the proposed clinical trial
• should include a discussion of the rationale for the investigational drug’s
intended dose, duration, schedule, and route of administration in the
proposed trial.

10. Previous human experience with the
investigational drug
• If there has been previous human experience with the investigational drug, the
sponsor investigator is required to provide a summary of this information.
• If the investigational drug has been investigated or marketed previously, either
in the United States or other countries, detailed information relevant to the
safety of the proposed trial or the trial’s rationale must be provided.
• Any published material relevant to the safety of the proposed trial or to an
assessment of the drug’s effectiveness for its proposed investigational use
should be provided
• if the drug or drug combination has not been investigated previously, then
sponsor-investigator should contact the review division.

11. Other Important Information
• In certain circumstances, a sponsor-investigator may be
required to provide:
1. Drug dependence and abuse potential: If the investigational drug is a
psychotropic substance or otherwise has abuse potential, then
information describing related clinical trials and experience as well as
any appropriate animal data must be submitted
2. Radioactive drugs : Sufficient data from animal studies or human clinical
trials must be submitted to allow a reasonable calculation of radiation-
absorbed dose to the whole body and critical organs upon
administration to human subjects

12. Relevant Information
• If a device is to be used in conjunction with the investigational drug (e.g., a
nebulizer for an inhaled drug or a pump for continuous infusion for home
use), the FDA may require under 21 CFR 312.23(a)(11) other relevant
information on the manufacturer and model of the device to be employed
and a general description of relevant conditions of use (e.g., carrier gas, flow
rate, temperature), and whether the device is FDA-approved or cleared for its
intended use in the trial.

13. REFERANCE
• https://www.fda.gov/media/92604/download