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
Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81. The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
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
Key Points - On July 28, 2023, President Biden signed EO 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which aims to increase domestic manufacturing and...more
Strike 3 Holding, LLC is a prolific filer of federal copyright infringement actions. They have filed thousands of lawsuits across the United States in states like Illinois, Pennsylvania, New Jersey, New York, Florida, Texas...more
Please join us for the third episode of Wiley’s Federal Infrastructure Webinar series, a series of webinars that will bring together attorneys from across the firm to discuss current developments relating to the federal...more
When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old...more
On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more
After publishing the “New Board Concept Paper Conclusions” in December 2017, the Stock Exchange of Hong Kong Limited (the Exchange) issued on 23 February 2018 a consultation paper entitled “A Listing Regime for Companies From...more