Announcements

Welcome to Mofo Life Sciences

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

April 09, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
CARES Act of 2020: Guide for Drug and Device Companies
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The
... ›
April 03, 2020 - United States, COVID-19, Healthcare, Privacy + Data Security
HHS Suspends Penalties to Encourage Sharing of COVID-19 Data by Business Associates
On April 2, 2020, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that, effective immediately, it will be halting enforcement of certain HIPAA provisions in order to enable state and federal public health authorities and emergency operations
... ›
March 31, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Inspires Modifications and Quick Authorizations for Ventilators
By: Erin M. Bosman and Julie Y. Park
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Read our Class
... ›
March 26, 2020 - United States, COVID-19, Antitrust
Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis
The U.S. antitrust agencies – the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) – have recognized a need for “unprecedented cooperation between federal, state, and local governments and among private businesses to protect Americans’ health and safety” during the
... ›
March 25, 2020 - FDA, COVID-19, Healthcare
FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. Park
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based
... ›
March 24, 2020 - COVID-19, European Union, Regulatory, Intellectual Property
Hard Knocks Keep Coming for Europe’s Unified Patent Court
By: Wolfgang Schönig and Robert Grohmann
With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litigation system faces ever‑mounting challenges. Last Friday, the German Federal Constitutional Court declared that the German Act of Approval of the UPC
... ›
March 24, 2020 - FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action
Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis
By: Erin M. Bosman and Julie Y. Park
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical
... ›
March 22, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit
By: Erin M. Bosman and Julie Y. Park
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of
... ›
March 18, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Biotech, Healthcare, Pharma
FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers
By: Keunbong (KB) Do Ph.D.
On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health
... ›
March 12, 2020 - United States, COVID-19, Healthcare, Privacy + Data Security
OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)
By: Melissa M. Crespo
In response to the recent outbreak of the novel coronavirus (2019-nCoV or COVID-19) and associated preparation and response, the Department of Health and Human Services Office for Civil Rights (OCR) recently released a bulletin (the “Bulletin”) outlining how entities subject to HIPAA may share
... ›

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.

Welcome to Mofo Life Sciences

CARES Act of 2020: Guide for Drug and Device Companies

HHS Suspends Penalties to Encourage Sharing of COVID-19 Data by Business Associates

FDA Inspires Modifications and Quick Authorizations for Ventilators

By: Erin M. Bosman and Julie Y. Park

Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

By: Erin M. Bosman and Julie Y. Park

Hard Knocks Keep Coming for Europe’s Unified Patent Court

By: Wolfgang Schönig and Robert Grohmann

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

By: Erin M. Bosman and Julie Y. Park

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit

By: Erin M. Bosman and Julie Y. Park

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

By: Keunbong (KB) Do Ph.D.

OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)

By: Melissa M. Crespo