Topic Archives: Pharmaceutical & Medical Devices

November 22, 2021 - Coronavirus (COVID-19), Drug & Medical Device, Emergency Use Authorization (EUA), FDA, Pharmaceutical & Medical Devices

HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations …›

July 21, 2021 - Announcements & Press, Class Action, Mass Torts, Pharmaceutical & Medical Devices, Product Liability, Trials

Morrison & Foerster Achieves Top Ranking in Product Liability, Mass Torts and Class Action (Defense) for Pharmaceuticals and Medical Devices

Legal 500 US 2021 has recommended Erin Bosman, David Fioccola, and Jessica Grant, and named Julie Park among its “next generation” practitioners. The publication also recognized Morrison & Foerster as a top firm in Product Liability, Mass Tort and Class Action (Defense) for Pharmaceuticals …›

July 8, 2021 - Announcements & Press, Class Action, Consumer Products, Drug & Medical Device, Environmental Law, MDL, Mass Torts, Pharmaceutical & Medical Devices, Product Liability, Retail, Trials

Morrison & Foerster Is Recognized As Tier 1 Firm in Product Liability, Mass Torts, and Class Action for Consumer Products

Legal 500 US 2021 has named Erin Bosman, David Fioccola, Jessica Grant, Julie Park, James Schurz, William Tarantino, and Claudia Vetesi among their top product liability and class action practitioners nationwide. The publication also recognized Morrison & Foerster as a top Tier 1 Firm …›

April 30, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices

Mental Health During COVID-19: FDA Waivers for Digital Health Devices

By: Jean Nguyen

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 week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating …›

April 22, 2020 - Coronavirus (COVID-19), Emergency Use Authorization (EUA), FDA, Pharmaceutical & Medical Devices

FDA Uses EUAs Broadly in the Fight Against COVID-19

By: Julie Y. Park and Hilary R. Hoffman

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 Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel …›

April 9, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices, Product Liability

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 …›

March 30, 2020 - Coronavirus (COVID-19), Emergency Use Authorization (EUA), FDA, Pharmaceutical & Medical Devices

FDA Inspires Modifications and Quick Authorizations for Ventilators

By: Erin M. Bosman, Julie Y. Park, and Hilary R. Hoffman

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. Ventilator Modification Enforcement Policy On …›

March 24, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices

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

By: Erin M. Bosman, Julie Y. Park, and Hilary R. Hoffman

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 23, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices, Product Liability

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 …›

July 3, 2019 - Drug & Medical Device, FDA, Pharmaceutical & Medical Devices, Product Liability

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

By: Erin M. Bosman and Julie Y. Park

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. …›