PODCAST: Williams Mullen's Benefits Companion - Good News for the ACA in 2025
RoboCop: Overview of Corporate Basics and Compliance Filings
The Corporate Transparency Act
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
On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s...more
The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar on February 25, 2025, from 2:00 p.m. EST to 3:00 p.m. EST, providing additional information...more
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
Welcome to the latest edition of Fenwick’s Securities Law Update. This issue contains news on...more
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
Amidst challenges and conflicting demands from a variety of stakeholders, technology and life sciences companies have increased their voluntary disclosure regarding environmental, social and governance (ESG) concerns. Despite...more
The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more
Environmental, social and governance (ESG) concerns and how companies respond to them continue to generate scrutiny from a large number of stakeholders. Last year, in our ESG in Silicon Valley: A Look at the ESG Disclosure...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
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
For companies of all industries, ESG matters have become an area of intense focus. In addition to investor and activist pressure, the growth of ESG ratings – and proposed climate and broader ESG disclosure requirements in the...more
From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more
A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for which responsible parties were required to submit results to...more
Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more
Over the last few months the California Board of Pharmacy has been busy considering several changes to its current rules and how it regulates various entities under its purview....more
Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more
On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...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
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