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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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Publications

Published Works

GP-led transactions are in good health Estates Gazette

In a recent article for Estates Gazette, Ed Harris, Sian Owles, Nicholas Holman, Adam Brown and Elliot Weston explore what GP-led transactions are, the common motivations for their...

Published Works

Performance in a pandemic – 10 governance and shareholder considerations for performance-based compensation C-Suite, An Equilar publication | Issue 34, Fall 2020

The uncertainty and disruption caused by the pandemic has created a challenging situation for compensation committees that need to address the impact of the pandemic on their...

News

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled ...

News

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting...

News

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when...

News

FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework

On September 14, the U.S. Food and Drug Administration (FDA) announced that it released an eight-page update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot...

News

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or...

Published Works

COVID-19 and fund secondaries – how should pension schemes position themselves? Investment & Pensions Europe

Partners Ed Harris, Jeremy Pickles, Faye Jarvis and Adam Brown co-wrote an Investment & Pensions Europe article which focusses on how pension funds can best position themselves to take...

News

FDA finalizes policy on multi-function medical devices’ premarket submissions

On July 28, the U.S. Food and Drug Administration (FDA) issued the final guidance “Multiple Function Device Products: Policy and Considerations,” which describes FDA's...

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