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
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
Summary - The U.S. International Trade Commission (USITC) is soliciting public comment on the proposed expansion of a June 2022 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property...more
On February 1, 2023, the U.S. International Trade Commission (the “ITC”) initiated an investigation into the impact of intellectual property (“IP”) rights on the production, supply, and availability of diagnostics and...more
Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more
It is often observed (or asserted) that a fair compromise in a dispute has likely been reached when both sides are not particularly happy about it. This is not always the case, of course, and is more likely not to be the...more
While over 48% of the U.S. population is fully vaccinated, only about 15% of the world is. Such disparities have caused members of the World Trade Organization (WTO), such as India and South Africa, to call for a waiver of...more
In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...more
Over a year after the world shut down from the COVID-19 pandemic, many countries are beginning to see the light at the end of the tunnel that is a return to normalcy. Unfortunately, other countries are still deep in the...more
On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...more
On May 26, SBA Administrator Isabella Casillas Guzman began a series of hearings on the Hill that will continue through May 28. On May 26, she testified before the House Committee on Small Business in a hearing titled “An...more
Companies holding intellectual property in medical products used in the fight against COVID-19 should be aware of formal efforts by a group of nearly 60 developing countries, led by India and South Africa, to obtain a waiver...more