Hogan Lovells Publications

21 February 2019

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments"...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

19 February 2019

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

08 February 2019

On Tuesday, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance, "Principles of Premarket Pathways for Combination Products," with high-level...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

24 January 2019

Hogan Lovells Publications

24 January 2019

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...

Hogan Lovells Publications

14 January 2019

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and...