Steps Your Nonprofit Can Take to Mitigate Fraud Risks - Part 2
A Third Party's Perspective on Third Party Risk
Implications of the SEC Cybersecurity Disclosure Rule
Privacy Issues from Third-Party Website Tags
What's the Tea in L&E? Employee Devices: What is #NSFW?
Preparing for a Government Healthcare Audit
Tackling Credit Push Fraud: Understanding Nacha's Risk Management Package (Part Two) — Payments Pros: The Payments Law Podcast
Compliance into The Weeds: The Complexity of Risk Assessments
Behavioral Health Compliance
The Importance of Assessment Areas
RegFi Episode 8: The Technological Path to Outcomes-Based Regulation with Matt Van Buskirk
What Physicians Need to Understand About Balance Billing
What Nonprofit Board Leadership Needs To Know About Internal Investigations
Taking a Behavioral Approach to Compliance
Episode 291 -- Interview of Mary Shirley on Her New Compliance Book
ChatGPT Risks for Compliance Programs
Season 2 Episode 3 - The Role of Ethics and Compliance Programs in International Business
In the Boardroom With Resnick and Fuller - Episode 4
What Non-Financial Institutions Need to Know About Gramm-Leach-Bliley
"Board-er" Patrol in Privacy and Cyberattacks - Unauthorized Access Podcast
The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in U.S. Food and Drug...more
AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and...more
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more
The strategy aims to boost supply chain resilience of critical goods. On 17 January 2024, the government launched the Critical Imports and Supply Chains Strategy (the strategy), which aims to safeguard UK supplies of goods...more
In the December Public Company Watch, we cover key issues impacting public companies, including a preview of the SEC’s latest regulatory agenda, an update regarding the Fifth Circuit vacating the SEC’s share repurchase rules,...more
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more
Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more
Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug substance-related impurities (NDSRIs) in...more
In its proposals to revise the general pharmaceutical legislation (GPL) published this week, the European Union (EU) has recognised that the pharmaceutical product lifecycle can have negative impacts on the environment....more
The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft...more
The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more
FDA Continues to Focus on Identifying and Controlling Trace Impurities in Drugs - On December 23, 2021, the U.S. Food and Drug Administration (“FDA”) alerted drug manufacturers that FDA was investigating the root cause of...more
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
The European Medicines Agency (“EMA”) and the EU network of Health Technology Assessment (“HTA”) bodies are jointly reviewing a proposed framework for patient preference studies. The intention of the proposed framework is to...more
The COVID-19 pandemic has dramatically changed the way many of us now work. While this has created unforeseen opportunities, these changes have also brought with them serious, unanticipated consequences. One such consequence...more
Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more