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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
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
The U.S. Court of Appeals for the First Circuit recently upheld multiple misdemeanor convictions for two former medical device company executives under the Food, Drug and Cosmetic Act (FDCA). While the former executives...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
Introducing Our Secret Plan to Fight Inflation - It’s simple: Don’t fall afoul of the FTC - ’Twas Ever Thus - Every year, like the swallows returning to Capistrano, the Perseid meteor shower, or a Real Housewives...more
On October 6, President Joe Biden announced that people convicted of marijuana possession under federal law were pardoned of their convictions, and he urged all governors to pardon those convicted of simple marijuana...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
Medical Technology Company President Convicted for Participation in $77 Million COVID-19 and Allergy Testing Scheme - On September 1, 2022, the president of Arrayit Corporation, a medical technology company in Silicon...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 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard....more
On May 28, 2019, the United States Department of Agriculture (USDA) issued a legal opinion to address questions raised by several hemp-related provisions of the Agricultural Act of 2018, better known as the 2018 Farm Bill....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
ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more
Last week, in United States v. Scully, the Second Circuit vacated the conviction of a distributor of pharmaceutical products on misbranding charges due to evidentiary issues surrounding his advice-of-counsel defense at trial....more
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more