As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medi

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure

The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distincti

The Federal Trade Commission (FTC) recently announced a review and open comment period for the Health Breach Notification Rule, 16 C.F.R. Part 318 (the “Rule”),

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 mil

Amid concerns about predatory acquisitions of weakened companies and strategic assets during the COVID‑19 crisis, more and more countries are restricting foreig

As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern.  Last we

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmet

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to

As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnos