News & Analysis as of

Enforcement Actions Patient Safety

Dechert LLP

Unprecedented Escalation of Injunction by French National Agency for Medicines and Health Products Safety

Dechert LLP on

In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Seattle - July 23rd, 8:25 am - 4:30 pm PDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Bradley Arant Boult Cummings LLP

The Government’s Watchful Eye on Fraud Stemming from Stem Cell Therapy

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

Holland & Knight LLP

FDA Issues Warning Letter Regarding Unapproved Stem Cell Products

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Hogan Lovells

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

Hogan Lovells on

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell...more

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