Podcast - Cybersecurity Roundup: Analyzing New and Proposed Rules for Contractors
Long-Term Part-Time Employee Eligibility Rules Now in Effect — Troutman Pepper Podcast
Exámenes de constitucionalidad a la reforma tributaria ¿en qué vamos?
Excitement, Turbulence & Confusion: The Top 10 Employment Law Issues That Affected Federal Contractors in 2023
The New Proposed Regulations on DAFs: Taxable Distributions and the Penalty Tax
New Proposed Regulations Defining Donor Advised Fund Terms
An Introduction to DAFs and Overview of the Newly Proposed DAF Regulations
Podcast: What Employers Should Know about the Pregnant Workers Fairness Act [More with McGlinchey, Ep. 62]
The Standard Formula Podcast | Bermuda Monetary Authority Proposes Enhancements to its Regulatory Regime
Monthly Minute | Current and Proposed Crypto Regulation
#WorkforceWednesday: AI Technology Regulations, Transparency in AI, OSHA's Permanent COVID-19 Standard - Employment Law This Week®
Overview of California’s New Proposed Cannabis Regulations
Proposed EU Regulation on AI - Impact and Ripple Effect
More CBD Certainty: Clearing Confusion over Hemp in New York State
JONES DAY TALKS®: Proposed Regs Implement FIRRMA, Expand CFIUS’s Jurisdiction Over Foreign Investments
Podcast: Health Reimbursement Arrangements
Qualified Opportunity Zone Fund Investments
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 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
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
Following the IRS’s issuance of guidance in Notice 2023-63 regarding R&D capitalization under Section 174, a working group of several Fenwick tax group attorneys commented to the IRS and the U.S. Treasury Department on...more
Report on Research Compliance 20, no. 12 (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more
After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more
After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would implement a new...more
On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more
California is taking steps to broaden its regulatory oversight of health care related transactions, joining a growing list of states that have recently either attempted to or have been successful in enacting similar...more
In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more
The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more
On May 3, 2022, the European Commission published a proposal for a Regulation on the European Health Data Space (EHDS) (“EHDS Regulation”, or “Proposal”). With the Proposal, the European Commission aims to make significant...more
On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...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
Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more
Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual. While the immediate focus may be on products that are...more
...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more
In 2019, we published analysis to help tech and life sciences companies navigate U.S. tax law changes, an evolving IP landscape and new privacy regulations such as the California Consumer Privacy Act. We also tracked venture...more
Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) proposed additional revisions to the Stark Law regulations (the...more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more
On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more