The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
On 3 June 2025, the UK Financial Conduct Authority (FCA)’s updated Enforcement Guide (ENFG or the Guide) came into force. The ENFG, which replaces the previous Enforcement Guide (referred to as ‘EG’) from 2007, describes the...more
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
Ohio- Statute of Limitations Under FDCPA- Bouye v. Bruce, 6th Cir. Nos. 21-6195/22-5016 (Mar. 1, 2023). In this appeal, the Sixth Circuit reversed in part the district court’s decision, finding that a claim brought...more
King & Spalding’s April Client Alert provided an overview of and practical advice related to issues that an employer should consider before conducting an internal investigation in the United Kingdom: privilege, privacy,...more
As we discussed in our April 27, 2020 blog post, nursing homes have become the focus of significant attention during the COVID-19 crisis. In many respects, the attention is well deserved: 1. Nursing homes traditionally...more
With cybercrime on the rise, organizations have increasingly found themselves subject to litigation or regulatory investigations related to breaches. Documents and information created before breaches, such as security...more