Publications

Hogan Lovells Publications

MDR single report exemption and ASRs: Coming to an end for most reporters

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...

Hogan Lovells Publications

FDA releases final guidance document on PMA manufacturing site change supplements

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA)...

Hogan Lovells Publications

The emergence of intelligent systems in health care

Hogan Lovells Publications

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available ...

Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Regulatory changes in Europe

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars.

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