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Streamlined regulatory pathways One of the biggest enablers of drug repurposing is the regulatory framework designed to expedite approvals for already-approved compounds. For repurposed drugs, early-stage trials such as Phase 1 or 2 might be sufficient, provided there is existing safety data on the compound,” Vyas explains.
With this extensive system in place, patients can trust that medicines with the same name will be consistent in quality no matter who manufactures it or where in the world it is made. Since manufacturers know the precise quality specifications, standards help make the approval process for genericmedicines more efficient.
The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus. Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The pandemic brought imbalances into sharp focus.
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