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
Government Funding Deadline, Healthcare Program Expirations Approach. Following recent House and Senate passage of their competing budget resolutions, Congress’ attention has now turned to the March 14, 2025, government...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
Two Individuals Indicted for Operating $25 Million Crypto-Fraud - On December 11, a federal court in California unsealed a superseding indictment, which charged two men with operating a $25 million cryptocurrency fraud...more
DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more
On May 26, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule titled: “Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug...more
Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: Cannoli Factory Feels the Heat over Alleged Wage...more
Breaking News- New Leadership at the FTC- •President Joseph R. Biden designated Federal Trade Commission (“FTC”) Commissioner Rebecca Kelly Slaughter as Acting Chair of the FTC . •As Commissioner, Chairwoman...more
DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more
This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more
This week in Washington: Congress remains in a district work period, while COVID-19 legislative talks continue....more
A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more
Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more
This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more
This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate...more
This Week: Because of the Blizzard of 2016—also known as “Snowzilla”—in Washington, D.C., and other parts of the East Coast, this is a combined issue... The House of Representatives opted not to come back to town until next...more
This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...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
Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more
- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback Statute. ...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
In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups Scheduled. ...more
In This Issue: Leading the News; Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more