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4/15/2026 6:59:06 PM | less than a minute read

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

Associate

Kyle Dolinsky

Partner

Get in touch

Samarth Parikh

Associate

Kyle Dolinsky

Partner

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).

Get in touch

Samarth Parikh

Associate

Kyle Dolinsky

Partner

Get in touch

Samarth Parikh

Associate

Kyle Dolinsky

Partner

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