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Center for Drug Evaluation and Research (CDER) New Guidance Prescription Drugs

Hogan Lovells

FDA to Publish Guidance to Improve the Rx to OTC Switch Application Process

Hogan Lovells on

The pressure is building for the U.S. Food and Drug Administration (FDA) to take steps to facilitate making more drugs available over-the-counter (OTC) that currently require a prescription. As part of the Congressional...more

Akin Gump Strauss Hauer & Feld LLP

FDA Continues Focus on Rare Disease Drug Development, Announces Evidence Principles

On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs...more

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