The Justice Insiders Podcast: Crime & Punishment - Part 2
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Episode 119 -- The Ericsson FCPA Settlement
Episode 116 -- Alstom Executive Convicted of FCPA and Money Laundering Offenses
DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme - On April 26, the US Department of Justice (DOJ) announced that Manishkumar Patel pleaded guilty to charges related to a $50 million health care fraud and...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
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
On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...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 Channel Medsystems, Inc. v. Boston Scientific Corporation, the Delaware Court of Chancery rejected an attempt by Boston Scientific to terminate and thus avoid consummating a merger agreement with Channel on the grounds...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more
Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...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
LEGISLATION, REGULATIONS & STANDARDS - DOJ Announces Guilty Plea in E. Coli Prosecution - The U.S. Department of Justice (DOJ) has announced that Memet Beqiri had pleaded guilty to “a charge related to his meat...more
LEGISLATION, REGULATIONS & STANDARDS - Illinois Adds Sesame to Allergen-Labeling Regulations - Illinois has passed a law requiring businesses to indicate on food labels whether a product contains sesame. The amended law...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
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...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