Investigational New Drug Application

Type: Information Object

Status: Planned
Industry Sector: Pharmaceuticals & Life Sciences
Sensitivity Level: Restricted
Personal Information: No PII

Description:
Regulatory filing authorizing use of an investigational drug in human clinical trials.

Accessed by Application(s):

• Regulatory Information Management System

 Yes

Attributes

Order	Name	Description	Type	Cardinality	Example value
1	Application ID	Unique identifier for the investigational new drug application	GUID	Mandatory
2	Product ID	Reference to the investigational product	Reference	Mandatory
3	Sponsor	Organization sponsoring the application	String	Mandatory
4	Indication	Disease or condition under investigation	String	Mandatory
5	Regulatory Authority	Authority receiving the application	String	Mandatory
6	Submission Date	Date when the application was submitted	Date	Mandatory
7	Application Status	Current status of the application	Enumeration	Mandatory
8	Authorization Date	Date when clinical trial authorization was granted	Date	Optional

 Yes
 
 Planned
 No PII
 Restricted
 Pharmaceuticals & Life Sciences
 Regulatory filing authorizing use of an investigational drug in human clinical trials.

✏️ Edit