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Regulatory Oversight › Drug Approvals › Food and Drug Administration (FDA)

Hogan Lovells

FDA launches “Elsa” AI tool to aid drug approvals

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The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more

Hogan Lovells

New drug marketing applications: how do EMA and FDA compare?

Hogan Lovells on

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more

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