Role of IND in a Clinical Trial
Mukuntha Krishnan Srinivasan
![Mukuntha Krishnan Srinivasan]()
Mukuntha Krishnan Srinivasan
Databricks Certified Data Analyst | PCEP Certified Python Programmer | Health Care | Clinical Trials | Azure Databricks | SQL | ISTQB QA Manager | H1B | I-140 Approved
As per National Institute of Health, an Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
Sponsor or CRO have to submit IND and get it reviewed and approved by FDA to kickstart a clinical trial.
The steps involved in filing and obtaining FDA approval for IND is pictorially illustrated below.