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Regulatory Oversight › Regulatory Requirements › Premarket Approval Applications

Gardner Law

Are FDA Review Timelines Slipping? What Companies Need to Know

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As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

Hogan Lovells

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

Hogan Lovells on

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more

Hogan Lovells

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What...

Hogan Lovells on

On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more

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