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
The US Department of Commerce’s Bureau of Industry and Security (BIS), which administers the Export Administration Regulations (EAR) and regulates most exports from the United States, announced further updates to the process...more
Summary - On August 23, 2023, the U.S. Department of Commerce (“Commerce”) published its final affirmative circumvention determinations for solar products exported from Cambodia, Malaysia, Thailand and Vietnam. Commerce’s...more
We recently wrote about “Phase 2” of the federal contract mandate, effective August 13, 2020, that prohibits federal prime contractors from using equipment, systems, or services provided by certain Chinese entities “as a...more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
U.S. to Give Eight Nations Oil Waivers Under Iran Sanctions, Official Says - "The U.S. has agreed to let eight countries - including Japan, India and South Korea - keep buying Iranian oil after it reimposes sanctions on the...more
ANTICORRUPTION DEVELOPMENTS - DOJ Extends FCPA Corporate Enforcement Policy to Misconduct in Mergers and Acquisitions - On July 25, 2018, in a speech to the Ninth Global Forum on Anti-Corruption Compliance in High Risk...more
On October 18, 2015, the day on which the Joint Comprehensive Plan of Action (“JCPOA”) became effective (“Adoption Day”), the U.S. Department of State (“State Department”) issued contingent waivers of certain extraterritorial...more