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  • In order for researchers to investigate the safety and effectiveness of novel therapeutic agents in human subjects, this procedure is crucial and goes beyond simple bureaucratic formalities. These slots are frequently in high demand, so businesses must prepare their submissions carefully in order to increase their chances of being accepted. The regulatory framework designed to guarantee that novel drugs are thoroughly assessed prior to going on sale is the foundation of the idea of IND slots. The FDA reviews each IND submission carefully, looking at the overall risk-benefit profile, the drug's preclinical data, and the design of the proposed study.
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  • It is impossible to exaggerate the importance of IND slots in drug development. They act as a point of entry for novel treatments into clinical trials, which are crucial for establishing whether a medication is both safe and effective for use in people. A pharmaceutical company cannot lawfully start clinical trials without an IND slot, thereby stalling any potential advancements in patient treatment options. Attending to Unmet Medical Needs.
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