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Life Sciences › Public Health › Risk Management

Butler Snow LLP

Junk Science: What Courts are Seeing and How It Affects Us: A Judge’s Eye View

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Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Seyfarth Shaw LLP

Outlook of China’s Health Care Sector in Light of COVID-19

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China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more

Epstein Becker & Green

Recommendations for Health Care Providers in Managing COVID-19

Epstein Becker & Green on

On March 11, 2020, the World Health Organization declared that COVID-19 is now a pandemic. The effects continue to be felt in the United States, which now has well over 1,000 confirmed novel Coronavirus disease (COVID-19)...more

Sheppard Mullin Richter & Hampton LLP

How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities

Sheppard Mullin Richter & Hampton LLP on

The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented. Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic. The US...more

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

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U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more

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