Moving Beyond the Usual Helpline Data
Episode 381 -- NAVEX's 2025 Annual Hotline Report
CSC Guidance Unveiled: NIL Enforcement and Implications for Collectives — Highway to NIL Podcast
Daily Compliance News: July 22, 2025, The I-9 Hell Edition
New Virginia "Workplace Violence" Definition and Healthcare Reporting Law: What's the Tea in L&E?
What the One Big Beautiful Bill Act Means for Employers - #WorkforceWednesday® - Employment Law This Week®
Understanding the New Overtime Tax Policies in the Big Beautiful Bill
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
(Podcast) California Employment News: Creating the Report for a Workplace Investigation – Part 4 (Featured)
California Employment News: Creating the Report for a Workplace Investigation – Part 4 (Featured)
Podcast - Navigating the Updated SF-328 Form
Five Tips for a New Public Company Director
Compliance Tip of the Day: Internal Control Deficiencies
Daily Compliance News: July 7, 2025 the Disaster on the River Edition
First 100 Days of the New HSR Rules with Antitrust Partner Kara Kuritz
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Compliance Tip of the Day: What is a Gap Analysis
Compliance into the Weeds: Autonomous AI Whistleblowing Misconduct
REFRESH Nonprofit Basics: Federal Tax Filing Deadlines and Penalties
(Podcast) California Employment News: Back to the Basics of Employee Pay Days
California is rolling out two climate disclosure laws—SB 253 and SB 261—that will soon require major companies that operate in California to publicly report their greenhouse gas (GHG) emissions and climate-related financial...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more
This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more
Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more
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