[Webinar] EHS in the Cannabis Industry: What Happens When the E stands for Enforcement?
#WorkforceWednesday: OSHA ETS Coming Soon, OSHA Cracks Down on States, and EEOC Updates Guidance - Employment Law This Week®
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Subro Sense Podcast - Unpacking Product Claims Against Amazon
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Taking Notice of Notice Letters
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
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
On August 18, 2020, the Financial Crimes Enforcement Network (FinCEN), which is the primary regulator and administrator of the Bank Secrecy Act (BSA), issued a statement on enforcement of the BSA. The requirements of the BSA...more
Report on Research Compliance 17, no. 4 (April 2020) The Food and Drug Administration has accused a University of Michigan physician and professor of conducting research for more than three years after his approval from the...more
This week the FTC announced yet another batch of enforcement actions against companies for misrepresenting their participation in the EU-US and US-Swiss Privacy Shield Frameworks. Since the beginning of the year, the FTC has...more
If you’ve ever wondered whether Big Brother is watching you online, the answer is yes. I’m not just referring to the big data and privacy breaches such as Equifax’s recent $700 million settlement which has been reported in...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more