Investigational New

Drug (IND)
Name: Mohit Sharma
PRN No: 21040781018
Submission: Set 2 PPT-Course 2
Batch: July 2021- Dec 2021
Programme: CMW
Units
1.What is IND (slide 3)
2.Components of IND (slides 4-5)
3.Types of IND (slide 6)
4.IND categories (slide 7)
5.Timing of IND submission (slides 8-9)
6.IND application format (slide 10)
7.IND review process (slide 11)
8.References (slide 12)
What is IND ?
Food and Drug Administration’s Investigational New Drug (IND)
program is the means by which a pharmaceutical company
obtains permission to start human clinical trials and to ship an
experimental drug across state lines (usually to clinical
investigators) before a marketing application for the drug has
been approved (Wikipedia, n.d.).
Components of IND
Main components of an IND are:
1. Description of drug substances
2. Chemistry, manufacturing and control information
3. All known pre-clinical information
4. Any previous human study reports
5. Investigator’s brochure
6. Clinical development plan.
Components of IND

(ComplianceOnline, n.d)
Types of IND

(ComplianceOnline, n.d)
IND categories
1. Commercial: Permits sponsor to collect data on clinical
safety and effectiveness needed for application for marketing
in the form of NDA.

2. Research: Permits the sponsor to use the drug in research to

obtain advanced scientific knowledge of new drug. No plan to
market the product (U.S. Food & Drug Administration, 2021).
Timing of IND submission
1. A sponsor must submit an IND to the FDA prior to conducting
any human clinical trials with an unapproved drug.
2. 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.
3. An IND can be issued to a company, a government agency or
an individual investigator (ComplianceOnline, n.d).
Timing of IND submission

(Nature, 2003)
IND application format
1. Cover sheet (Form FDA 1572)
2. Table of contents
3. Introductory statement and a general investigation plan
4. Investigators brochure
5. Protocols
6. Chemistry, manufacturing and control information
7. Previous human experience with the drug
8. Other relevant information like No. of copies to be submitted.
9. Any changes in protocols (ComplianceOnline, n.d).
IND Review process

(ResearchGate, 2013)
References
1. Wikipedia. (n.d). Investigational New Drug. Retrieved from:
https://en.wikipedia.org/wiki/Investigational_New_Drug
2. ComplianceOnline. (n.d). Clinical Trials - Providing relevant information in the IND
application. Retrieved from:
https://www.complianceonline.com/resources/clinical-trials-providing-relevant-inf
ormation-in-the-ind-application.html
3. U.S. Food & Drug Administration. (2021). Investigational New Drug (IND)
Application. Retrieved from:
https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-appli
cation
4. Nature. (2003). The Common Technical Document: the changing face of the New
Drug Application. Retrieved from: https://www.nature.com/articles/nrd990
5. ResearchGate. (2013). Investigational New Drug Application. Retrieved from:
https://www.researchgate.net/figure/Investigational-New-Drug-Application_fig2_
263657519