Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Attorney General (AG) Pam Bondi has issued a memorandum titled “Preventing the Mutilation of American Children” (the Memo) to select Component Heads of the Department of Justice (DOJ). Released on April 22, 2025, the Memo...more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more
Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
The False Claims Act (the “Act”) imposes liability on those who “’knowingly’ present, or cause to be presented, ‘a false or fraudulent claim for payment or approval’” to the government. Persons who act in “deliberate...more
In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more
The U.S. Court of Appeals for the Fourth Circuit recently upheld the dismissal of a False Claims Act (FCA) suit against Omnicare, Inc., in which the relator alleged that certain drugs repackaged by Omnicare’s subsidiary were...more
In This Issue: - Top News ..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations ..Glitches and Demand Lead to Marketplace Frustration ..HHS Delays Small...more
Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more
Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more
The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more
While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more