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Artificial Intelligence: World First Rules Are Coming Soon – Are You Ready? (Part 2)

Nowadays, artificial intelligence (“AI”) is all around us. Previously, we took a look at the approaches being proposed to regulate AI at a pan-EU level and in the UK. In this part 2 article, we take a look at what...more

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts...

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling...more

Restrictions on Lawyer Ads Involving Drugs and Medical Devices Are Not Unconstitutional, Says Federal Court

The Fourth Circuit has found that a West Virginia state law restricting how attorneys can solicit clients in pharmaceutical and medical device cases does not violate the First Amendment. At the end of April, a three-judge...more

U.S. courts continue to apply narrower view of PREP Act immunity

During the past 12 months, we’ve published several articles on the 10 March 2020, Public Readiness and Emergency Preparedness Act (PREP Act) Declaration related to COVID-19 as well as covering the five amendments to the PREP...more

International Products Law Review

New Sustainable Batteries Regulation: Reflections from our Global Products Law team Following the closure of the European Commission’s recent consultation period, the European Parliament and Council are set to consider a...more

Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more

International products law review 2020: Issue 78

On 18 February 2020, the French Ministry of Economy and Finance announced the launch of a new online platform called SignalConso, an easy-to-use public service enabling individuals to report any consumer law issue they may...more

First courts consider application of PREP Act Immunity in the context of removal

Earlier this year, we published various articles breaking down the March 10, 2020 Public Readiness and Emergency Preparedness Act (PREP Act) Declaration (the Declaration) related to COVID-19....more

HHS Issues Advisory Opinion Encouraging a Broad Reading of its PREP Act Declaration

On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more

Navigating Limits on Product Liability under the PREP Act for COVID-19 Clinical Trial Activities

While numerous entities are responding with impressive speed and diligence in working to develop and deploy various COVID-19 countermeasures, some from the Plaintiffs bar are already putting up online advertisements offering...more

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