John Wick - What You Need To Know about the Corporate Transparency Act
Cannabis Law Now Podcast: Cannabis Companies and the Corporate Transparency Act
US Expatriate Tax Planning - Part 2 - A Podcast with Janathan Allen
EEO-1 Filing After June 4: What to Do Now, and How to Prepare for Next Year - Employment Law This Week®
Examining FinCEN FAQs, Proposed Legislation and Other CTA Developments
US Expatriate Tax Planning - Part 1 - A Podcast with Janathan Allen
AGG Talks: Cross-Border Business - Episode 12: A General Counsel’s Map for International Business Expansion - Part 2
AGG Talks: Cross-Border Business - Episode 12: A General Counsel’s Map for International Business Expansion - Part 1
Navigating the Corporate Transparency Act - Payments Pros – The Payments Law Podcast
DE Under 3: OMB Announced Finalized Overhaul to Federal Race & Ethnicity Data Collection Standards
Webinar: Corporate Transparency Act
What Nonprofit Leaders Need To Know About the Corporate Transparency Act
Regulatory Phishing Podcast - The Impact of Cybersecurity Compliance on Corporate Transactions
Meeting Cancer Reporting Requirements
DE Under 3: Potential Elimination of EEO-1 Type 4 & 8 Reports
#WorkforceWednesday: Pregnant Workers Fairness Act Takes Effect, EEO-1 Report Filing Start Date Pushed Back, DOL Clarifies FMLA Leave for Paid Holidays - Employment Law This Week®
DE Under 3: Kotagal Becomes Third Democrat on the EEOC Commission; Julie Su Nomination is Now Defunct
CFPB's Section 1071 Final Rule (Part 2): Deep Dive on Data Collection and Discouragement - The Consumer Finance Podcast
CFPB’s Section 1071 Final Rule (Part 1): A General Overview - The Consumer Finance Podcast
[Podcast] Top 5 Takeaways from New Jersey’s 2023 Pay-to-Play Reform
On June 25, 2024, Health Canada published a notice of intent and Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028, relating to Health Canada’s plan over the next 4 years to address...more
Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19...more
Pharmaceutical companies that have provided investigational drugs to patients under the Right to Try law should be prepared to comply with the U.S. Food and Drug Administration’s (FDA’s) reporting requirements by March 31,...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more
As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more
The federal Food and Drug Administration may be putting patients’ safety at serious risk by allowing medical device makers to self-police their products, notably in making crucial determinations in reporting to the agency the...more
The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more
Report on Medicare Compliance 29, no. 42 (November 23, 2020) - Medicare administrative contractors (MACs) will be coming to 911 hospitals for overpayments caused by unreported manufacturer credits for recalled or...more
Each year, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues dozens of audit reports. While each is important in its own way, some stand out with language that appears to reflect...more
This week, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert providing insight into speaker programs put on by drug and medical device companies that the OIG considers signs of potential fraud. Generally,...more
In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under...more
Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more
AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more
On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more
FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more
The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more
WLG has collaborated with members to present a series of meetings and workshops to connect and educate members during the month of May. The Life Sciences Group will host a webinar "International Regulatory Initiatives to...more
The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the...more
Recently, health care providers – in particular hospitals – have been requested by the federal government to share data related to the treatment of COVID-19 (coronavirus) patients and have been ordered by the Ohio Department...more