This is a brief note of the IND application intended for peers who just started learning the IND with very little understanding. Please refer to FDA website for more detail, but it will take some time. Here is the quick guide for you within a minute to grasp the outline of the IND.
Why IND is required?
The federal law “requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. “
What is IND application?
IND application is the process a drug company(sponsor) that apply for permission from federal health organization, FDA for the US, to use the drug in human and for a specific medical purpose.
How many types of IND
There are two categories and three different types. So your drug should fall in on of the six types as shown in the below table.
Commercial: means the purpose of the application is for marketed use in patients.
Research: means it is purposed for scientific research only, which will not resulted in the approval of the drug for patients.
Investigator IND is the typical type of application which require complete package of supportive data and undergo full process of review.
Emergency use IND is a special case only cab be used under very urgent and serious situation.
Treatment IND is an experimental drug shows exceptional clinical results in treating serious deadly disease before the clinical study is completed.
| categories/types | Investigator IND | Emergency Use IND | Treatment IND |
| Commercial | 1 | 2 | 3 |
| Research | 4 | 5 | 6 |
What are needed for IND application?
1: The data package which in the preclinical study proved the the drug safe for human use and effective for treating a disease. It includes the in vivo and in vitro toxicology and pharmacology study.
2: Manufacturing information that ensure the drug can be produced reliably and consistently. It includes the drug master file (DMF) which records the chemistry, manufacturing and control of quality for the drug.
3:Clinical Protocols and Investigator Information. These are the detailed protocol to guide the clinical studies.