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
The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more
On May 9, 2025, the White House issued an Executive Order, “Fighting Overcriminalization in Federal Regulations,” that seeks to place limits on the criminal enforcement of regulatory offenses, particularly those that impose...more
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...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
I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
The U.S. Department of Justice’s (DOJ) Consumer Protection Branch works with other branches and federal law enforcement agencies to investigate and prosecute civil and criminal violations of the nation’s consumer protection...more
In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more
DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more
21 U.S.C. § 331: Selling Counterfeit Drugs - Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - While expressing their “great disappointment,” the University of Michigan (U-M) Board of Regents on Jan. 16 announced the immediate removal of Mark Schlissel as...more
Report on Research Compliance 19, no. 2 (January 27, 2022) - The trial was to be like any other that the clinical research organization (CRO) would oversee. The six-month study, known as VESTRI, would involve pediatric...more
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more
In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
In what may be the beginning of a wave of enforcement actions, the Justice Department charged an organization and its leadership with dual healthcare and securities fraud charges. The prosecution underscores the risks facing...more
LEGISLATION, REGULATIONS & STANDARDS - House Passes Cannabis Banking Bill - The U.S. House of Representatives has passed the SAFE Banking Act, which allows financial-service firms to work with “cannabis-related...more
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
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
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...more
For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more
As we enter 2016, adulterated food-related investigations are leading the headlines—and should be leading companies in the food and beverage industry to ask what they can do to prevent and prepare for a potential outbreak on...more