Ad Law Tool Kit Show – Episode 11 – State Attorney General Investigations
Compliance Tip of the Day: Cross Border Investigations, Part 1
Better Investigative Interviewing
What to Do If the Government Knocks on Your Company’s Door … or Breaks It Down – Speaking of Litigation Podcast
Bank Investigations and Enforcement Actions: Lessons Learned — The Consumer Finance Podcast
PLI's inSecurities Podcast - Opening the Securities Enforcement Answer Book
AGG Talks: Antitrust and White-Collar Crime Roundup - The Mar-a-Lago Trump Indictment
AGG Talks: Antitrust and White-Collar Crime Roundup - Inside the World of No-Poach Investigations and Indictments
Healthcare Providers: Make Sure You Know When You Need a Criminal Attorney
Why Your Data is Key to Reducing Risk and Increasing Efficiency During Investigations and Litigation
State AG Pulse | State AGs and Feds: The Dynamics of Influence & Collaboration
The Risk Roundtable: Pre-Existing Conditions and Abdullah Credits in New Jersey Workers' Compensation
The Justice Insiders Podcast: Feds Danske to a New Tune
The Rules They Are A-Changin’: CMS Proposes a Significant Change to the 60-Day Repayment Rule
Predatory Behavior Alleged Against OSHA Addressed During Orange County Board of Education Board Meeting Led by Greg Rolen
Early Returns with Jan Baran Podcast: There's a New Chair in Town – Dara Lindenbaum and the FEC Agenda Looking Towards 2024
Evaluating Fraud Under the Bank Secrecy Act - The Crypto Exchange Podcast
How Law Firms and Lobbyists Can Work Together: A Look Into Lobbyists’ Role Among State AGs - Regulatory Oversight Podcast
Torres Talks Trade Podcast- Episode 13- When Government Agencies Come Knocking
Keeping Up With the Bureau Episode 1: Overview of CFPB and State AG Initiatives/Expansion - The Consumer Finance Podcast
On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
Summary - On June 10, 2024, the District Court for the District of New Jersey ordered Teva to delist five patents from the Orange Book for ProAir® HFA (albuterol sulfate) Inhalation Aerosol. The patents were directed to...more
The European Commission has launched its first investigation into a non-EU country's procurement practices leveraging its new tool, the International Procurement Instrument. This investigation looks at the public procurement...more
The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more
Drug and device manufacturers doing business in Nevada have upcoming filing deadlines in March, April, and June. By June 1, 2024, compliance officers must sign and submit a certification to the Nevada Board of Pharmacy to...more
Whether you manufacture a Class I elastic bandage or a Class III deep-brain stimulation device, understanding when to report a medical device complaint is critical and is also required for all FDA regulated medical devices....more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more
n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more
For diabetic patients and the doctors who treat them, blood sugar levels are crucially important. However, the traditional method of testing one’s blood sugar with a pin-prick is undesirable for many patients, which leads to...more
It was another busy month at the ITC. A Final Determination was issued by the Commission in three Section 337 Investigations: Certain Laparoscopic Surgical Staplers, Reload Cartridges, and Components Thereof, Inv. No....more
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
The SEC recently settled an enforcement action against Mylan N.V., claiming Mylan failed to timely disclose to investors a possible loss relating to a nearly two-year Department of Justice probe into whether Mylan...more
On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements...more
The U.S. Food and Drug Administration (FDA) just issued draft guidance on the Use of Electronic Health Record Data in Clinical Investigations for comment within the next 60 days. The guidance is intended to assist all...more
On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more
In the wake of a recent U.S. Department of Health and Human Services Office of Inspector General ("OIG") investigation, physicians with ownership interests in medical device distributorships and hospitals should prepare for...more
A recent article in the Antitrust Law Journal titled “A Survey of Evidence Leading to Second Requests at the FTC,” by Darren S. Tucker, an attorney advisor to a FTC Commissioner who reviewed non-public information on the...more
"I've long maintained that there are three possible routes to repeal of ObamaCare: the courts, the presidential election, and our constitutional responsibility for oversight. With two of them having come up short, the third...more