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
Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more
On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more
Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more
On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that...more
On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...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
A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...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
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
Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June,...more
The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more
Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more
Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more
On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more
“Didn’t we just do this?” might be the first question asked by many health plan sponsors and administrators when gearing up to complete 2022 prescription drug reporting by June 1, 2023. The answer to that question is both...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
With the enactment of major drug pricing reform—including the Inflation Reduction Act (IRA), which arguably made the most significant changes to U.S. prescription drug pricing regulations in history—the reporting of drug...more
On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential...more
Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting...more
Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules...more
In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more
Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP) has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include: ...more
As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more