Publications

Hogan Lovells Publications

Life sciences and health care horizons 2019

Hogan Lovells Publications

Brexit snapshot: Medical Devices

Do you hold a CE certificate of conformity issued by a UK notified body? Are your manufacturing activities, authorised representative, suppliers, customers or contracting parties located in ...

Hogan Lovells Publications

Podcast series: False Claims Act 2018 and the road ahead

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA...

Hogan Lovells Publications

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments"...

Hogan Lovells Publications

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

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...

Hogan Lovells Publications

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward...

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