What does INDA mean in FDA
INDA stands for Investigational New Drug Application- this is a request submitted to the FDA (Food and Drug Administration) in order for a new drug to be used in clinical research trials. It includes information on the preclinical, nonclinical, and clinical studies that have been conducted on the drug. If approved, it grants permission to use the drug in an investigation of its effects on humans. The purpose of an INDA is to provide evidence that a proposed drug has reasonably safe properties for use in human trials.
INDA meaning in FDA in Governmental
INDA mostly used in an acronym FDA in Category Governmental that means Investigational New Drug Application
Shorthand: INDA,
Full Form: Investigational New Drug Application
For more information of "Investigational New Drug Application", see the section below.
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Essential Questions and Answers on Investigational New Drug Application in "GOVERNMENTAL»FDA"
What is an Investigational New Drug (IND) application?
An Investigational New Drug (IND) application is a request to the United States Food and Drug Administration (FDA) from a drug sponsor seeking permission to conduct clinical trials of a new drug in humans. The IND includes all preclinical data, as well as information on the manufacture and quality control processes for the drug. It also includes information regarding how the clinical trial will be conducted, including safety monitoring measures
Final Words:
In summary, an Investigational New Drug Application (INDA) is a document which must be submitted to the FDA prior to beginning clinical trials involving any new drugs intended for human use. It includes information on preclinical studies such as laboratory tests conducted on animals, non-clinical studies or safety data, and related scientific literature published about the product under consideration. By reviewing this application, the FDA can evaluate any potential risks associated with using a proposed new drug before granting permission for its use in clinical investigations of its effects on humans.