Concept information
social science subjects
health and social care
health care management
pharmaceuticals and clinical trials
...
quality of health care
health care evaluation mechanisms
evaluation studies as topic
drug approval
...
quality of health care
health care evaluation mechanisms
evaluation studies as topic
drug approval
...
quality of health care
health care evaluation mechanisms
evaluation studies as topic
drug approval
...
quality of health care
health care evaluation mechanisms
evaluation studies as topic
drug approval
Preferred term
investigational new drug application
Definition(s)
- A “Notice of Claimed Investigational Exemption for a New Drug” (IND) is required under law to be submitted for any new chemical entity, biological, or antibiotic, before it is to be clinically evaluated in human subjects. Section 505 (a) of the federal Food, Drug, and Cosmetic Act states, “No person shall introduce into interstate commerce any new drug unless there is for that drug an approved New Drug Application or an effective IND.” There are three types of INDs: 1. [Source: Encyclopedia of Health Care Management; Investigational New Drug Application]
Broader concept(s)
Belongs to group
URI
http://data.loterre.fr/ark:/67375/N9J-G190PJBF-X
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