What is the purpose of an Emergency Use IND?

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The purpose of an Emergency Use IND (Investigational New Drug application) is primarily to allow for the use of an investigational drug in emergency situations when no alternatives are available, and there is an immediate need for treatment. This mechanism permits healthcare providers to access drugs that have not yet undergone the usual lengthy review processes, making it possible to treat patients who may not survive without the drug. It directly caters to situations where time-sensitive decisions are critical for patient care, thereby addressing urgent medical needs.

In contrast to this, the other options are not aligned with the primary intent of an Emergency Use IND. Collecting data for clinical trials pertains to ongoing studies and is not specifically about addressing emergencies. The authorization of marketing for a new drug is a separate regulatory process that occurs after extensive evaluations and is well-defined within the FDA's New Drug Application (NDA) process. Evaluating the safety of existing drugs falls under routine post-market surveillance and related studies, rather than the emergency framework established for immediate access to investigational treatments.

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