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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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News

Five highlights from FDA’s new AI device regulation Action Plan

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part...

News

STeP’ing up: FDA advances expedited device review program, set to begin in March

On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for...

News

Final FDA combination product guidance encourages application-based feedback pathways

The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it...

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Looking ahead to 2021: AI – A brave new world?

In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most...

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Election 2020 Snapshot: Impacts of the U.S. election for the life sciences and health care industry

On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series...

News

HHS ends FDA Unapproved Drugs Initiative, seeks to limit which drugs require FDA approval

On November 20, 2020, the U.S. Health and Human Services Department (HHS) announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved...

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Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations...

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Medical devices in the EU - Update on EUDAMED database: The first module is here!

The first module of the European database on medical devices, EUDAMED, also referred to as the Actor registration module, will be made available to EU Member States and economic operators...

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A step in the right direction: Encouraging diversity in clinical trial populations

On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria,...

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