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.
News
16 January 2021
On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) published a final rule that, for the first time, adopts a regulatory standard for determining whether a ...
News
15 January 2021
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
12 January 2021
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...
Insights
Registered Content
17 December 2020
The CNEDiMTS is the French National Authority for Health Committee which evaluates, in particular, medical devices in view of their reimbursement by the French health insurance scheme. The...
News
08 December 2020
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...
News
07 December 2020
On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main...
News
01 December 2020
Following on last October’s publication of two proposed rules, the Department of Health and Human Services (HHS) published on November 20 two final rules intended to “modernize...
News
19 November 2020
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...
News
12 November 2020
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,...
