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
In the backdrop of uncertainties surrounding Deferred Action for Childhood Arrival (DACA) and the ongoing congressional deadlock, hundreds of thousands of DACA recipients, often referred to as ‘Dreamers’, continue to make...more
Federal and state agencies continue to remain active this year, particularly with regard to laws that impact healthcare technology. As part of our ongoing efforts to track health technology-related legislation and...more
WHAT: The Office of Management and Budget (OMB) recently issued an update to its initial guidance on implementing the Build America, Buy America (BABA) provisions of the Bipartisan Infrastructure Law. This is the third set of...more
On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more
COVID-19 has created new, unexplored territory for employers. Even in a pandemic, it’s imperative that employers follow all EEO laws. Since COVID-19 is consistently evolving, it is important that employers continue to follow...more
In response to the spread of COVID-19 infections and questions from the provider community, the Centers for Medicare and Medicaid Services (CMS) Quality, Safety and Oversight Group (QSO) issued a series of three memoranda...more
Over the past several weeks, competing views have emerged from Capitol Hill and the SEC over how the Securities and Exchange Commission (“SEC” or “Commission”) should approach waivers of collateral consequences for parties...more
Final and Temporary Dividend Equivalent Regulations Issued – Some Good, Some Bad, And Some Ugly: On September 17, 2015, the Internal Revenue Service (“IRS”) released final and temporary regulations under Section 871(m),...more
As we discussed here, on March 12, 2014, the Division of Corporation Finance of the Securities and Exchange Commission (SEC) revised its previous guidance on granting waivers to well-known seasoned issuers (WKSIs) to continue...more