In this Issue:
- Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved
- European Union Proposes to Significantly Restrict PFAS
- Governor Kathy Hochul Vetoes New York Wrongful Death Bill
- First Circuit Affirms Summary Judgment in Zofran MDL
- FDA Cybersecurity Requirements for Medical Devices Passed into Law
- FDA Publishes Final Guidance on REMS Programs for Prescription Drugs
Environmental Edit
Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved
A federal appeals court dismissed a challenge to EPA's interim guidance for PFAS levels in drinking water, highlighting the obstacle that standing can pose to mounting a challenge to such interim agency actions. Read more »
European Union Proposes to Significantly Restrict PFAS
The European Chemical Agency’s proposal to severely restrict the use of PFAS may impact any companies who use PFAS or PFAS-containing materials, particularly those who import from or sell products to Europe. Read more »
Hot Topics
Governor Kathy Hochul Vetoes New York Wrongful Death Bill
Governor Kathy Hochul has vetoed a bill designed to expand wrongful death benefits in New York State, citing concerns for its potential impact on the economy, businesses, and the healthcare system. Read more »
First Circuit Affirms Summary Judgment in Zofran MDL
FDA does not have to expressly reject a label change for federal preemption to apply when FDA approves a label that is directly contrary to the warning sought by plaintiffs. Read more »
Regulatory Review
FDA Cybersecurity Requirements for Medical Devices Passed into Law
The Consolidated Appropriations Act of 2023, which takes effect in the U.S. on March 22, 2023, empowers FDA to ensure that medical devices meet certain minimum cybersecurity standards and authorizes FDA to establish cybersecurity requirements for “cyber devices.” Read more »
FDA Publishes Final Guidance on REMS Programs for Prescription Drugs
In January 2023, FDA published its Final Guidance on Risk Evaluation and Mitigation Strategies ("REMS") programs for prescription drugs. The Guidance provides recommendations to ensure that REMs documents are clearly articulated and align with FDA’s Structured Product Labeling format. Read more »