Cures 2.0: Will It Be Better Than the Original?
- It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of representatives is looking to enact follow-up legislation—“Cures 2.0.”... ›
BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives
By: Stacy Cline Amin and Hannah Rose ElsonOn July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a comprehensive summary of the efforts to change both the substance and the approach... ›
EUAs and the FDA’s Fight Against COVID-19: An Evolving LandscapeChristine Lentz , a Morrison & Foerster summer associate in our San Diego office , contributed to the writing of this article. The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in... ›
New Face Mask Performance Standard Has Consumers CoveredASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety... ›
COVID-19 Vaccines: And Then There Were Three (Again)On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others (produced by Moderna and Johnson & Johnson) have also been... ›
Is 2021 the Value-Based and Shared Savings Revolution?By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS regulations, OIG created new safe harbors... ›
Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap
By: Wolfgang SchönigOn Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific... ›
FDA Clinical Decision Support Software vs. EU’s Medical Device RegulationIn follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft Guidance (together the “CDS Draft Guidance”) and the MDR.... ›
Vaccine Production and State Intervention in the U.S.
By: Brigid DeCoursey BondocDuring the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes... ›
FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS
By: Jean NguyenU.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to... ›