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
Even the best company is not perfect. Mix ups, mathematical errors, transposing numbers, forgetting to sign a batch production, a supplier mix-up, or any one of an almost infinite potential glitches in the very complex...more
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...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
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
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
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation...more
The U.S. Environmental Protection Agency (EPA) is not the only federal agency that regulates per- and polyfluoroalkyl substances (PFAS). And states aren't the only ones scrutinizing PFAS in food packaging products. PFAS,...more
The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August...more
In the second edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administrations’ (FDA) expectations of investigators articulated in the recently released draft guidance....more
FDA and FTC Issue Cease and Desist Letters to Companies Selling Delta-8 Edibles - On July 5, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly sent cease and desist letters to six companies...more
The Food and Drug Administration (FDA) recently issued first-of-its kind draft guidance for investigational new drug (IND) applications involving psychedelic drugs. Citing the rise in interest in exploring the potential...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more
IV hydration clinics engage in sterile compounding activities (combining or mixing ingredients to create a custom drug/medicine for an individual patient), such as creating IV vitamin therapies, etc. This act of drug...more
The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...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
We invite you to enjoy a review of the food and beverage industry with bite size articles ranging from regulatory and real estate trends to litigation and M&A happenings. The past two years have seen significant changes...more
Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more
On March 25, 2022, the U.S. Food and Drug Administration (“FDA”) announced a public process to update the “health” nutrient content claim for food labeling. This process will include the agency’s review of a voluntary symbol...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