September 22, 2021 - FDA, Healthcare, United States
CMS Proposes to Repeal MCIT Final Rule
By: Dan Kagan
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable …›
September 15, 2021 - COVID-19, Healthcare, Pharma, United States
Is the Future of Telehealth in OIG's Hands?
Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of Inspector General (OIG) appear primed to audit telehealth services and ramp …›
July 26, 2021 - FDA, Healthcare, United States
Cures 2.0: Will It Be Better Than the Original?
By: Zachary Fuchs and Stacy Cline Amin
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 …›
July 15, 2021 - Antitrust, Healthcare, United States
BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives
By: Stacy Cline Amin and Hannah Rose Elson
On 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 …›
June 29, 2021 - COVID-19, FDA, Healthcare, Pharma, United States
EUAs and the FDA's Fight Against COVID-19: An Evolving Landscape
By: Zachary Fuchs and Bethany J. Hills
Christine 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 response to the …›
May 26, 2021 - European Union, Litigation
The European Commission's Take on Novel Genomic Techniques (NGTs) in Light of CJEU's Ruling in Case C-528/16
Summary - The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis …›
May 20, 2021 - Regulatory, United Kingdom
UK's new emissions trading scheme hosts first auctions
By: Liz Freeman Rosenzweig, David H. Kaufman, and Matthew Dunlap
Stephanie Pong, London trainee solicitor contributed to the writing of this article. On January 1, 2021, the UK launched its very own emissions trading scheme (the "UK ETS") exercising its autonomy since departing the EU. Under this scheme, companies operating in certain sectors can trade …›
May 13, 2021 - COVID-19, FDA, Healthcare, United States
New Face Mask Performance Standard Has Consumers Covered
ASTM 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 …›
May 11, 2021 - COVID-19, FDA, Healthcare, Pharma, United States
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 …›
May 6, 2021 - AI + Robotics, FDA
CTA Publishes New Standard for Healthcare AI
In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration's (FDA) recently published action plan for regulatory oversight of AI and machine learning-based medical software. FDA ultimately …›