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investigative new drug
noun
- a regulatory classification assigned by the U.S. Food and Drug Administration to an unproven drug, allowing its use in approved studies with human patients. : IND
Example Sentences
“Businesses are seeing this as a terrific opportunity” to get their applications for investigative new drug trials approved by the FDA — a process that can take years and generally requires the submission of extensive evidence from lab and animal studies.
Food and Drug Administration and public health regulations require safety and efficacy tests for new vaccines, which take more time, though the FDA can authorize drugs under an Emergency Investigative New Drug category.
She said the boys’ doctor from Sioux Falls, S.D., in April petitioned the FDA for what is known as an IND, or investigative new drug application.
But US doctors performing fecal transplants as treatments must now submit an Investigative New Drug application to the FDA with details about their protocols.
But in the past few weeks, he has turned away three patients while he submits the required Investigative New Drug application.
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