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FDA Announces a Single Pivotal Trial as the New Default Standard for All Drug Approvals and Unveils a Plausible Mechanism Framework for Individualized Therapies

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Samarth Parikh
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Kyle Dolinsky
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Samarth Parikh
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Kyle Dolinsky
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FDA shifts to a single pivotal trial default and issues plausible mechanism guidance to speed individualized therapies for rare genetic diseases.

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration (FDA), a federal agency of the Department of Health and Human Services (HHS).

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Samarth Parikh
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Kyle Dolinsky
Partner

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Samarth Parikh
Associate
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Kyle Dolinsky
Partner

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