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Food and Drug Administration (FDA) › Pre-approval

Goodwin

Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to...

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The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more

Sheppard Mullin Richter & Hampton LLP

Breaking Down FDA’s New Remote Monitoring Strategy

Sheppard Mullin Richter & Hampton LLP on

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance,...more

Knobbe Martens

Safe Harbor Defense Under 35 U.S.C. §271(e)(1) Requires That the Accused Activity Is Solely for Uses Reasonably Related to...

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AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen.  Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more

Knobbe Martens

FDA Approves EnteroMedics’ Implantable Obesity Treatment Device

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St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. ...more

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