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
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
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
Health care provider boards of directors have been put on notice—given these two recent Delaware court decisions - Clovis and Marchand—that courts may be willing to significantly extend a corporate board’s Caremark duty to...more
Two core principles of American criminal liability are: (1) a crime does not occur unless the accused has both criminal intent (mens rea) and commits a criminal act (actus reus); and (2) the intent and the act must occur at...more
As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more
In an important decision, on July 6, 2016, the Eighth Circuit Court of Appeals affirmed the prison sentences imposed on Jack DeCoster, and his son, Peter, under the “responsible corporate officer” doctrine (aka Park doctrine)...more
On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more
Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more
Three Senate Democrats recently introduced a bill that seeks to hold company executives of a product maker or seller criminally liable for knowingly "failing to inform and warn of serious dangers" associated with a product....more