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Physicians › Expanded Access Programs (EAPs)

Hogan Lovells

FDA Simplifies and Clarifies Expanded Access Program

Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

Morgan Lewis

FDA Issues Guidance on Expanded Access

Morgan Lewis on

The Agency improves the process for access to investigational drugs and biologics for patients who lack other options. On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more

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