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 June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
Public safety on the roadways is the chief objective of the Federal Motor Carrier Safety Regulations (FMCSRs). Some safety and operations teams will from time to time encounter unique circumstances where strict compliance can...more
On February 21, 2023, Treasury and the IRS issued T.D. 9972, finalizing regulations implementing the requirement to e-file certain information and tax returns. These regulations affect filers of partnership returns, corporate...more
The U.S. Centers for Disease Control and Prevention (CDC) have recently added vaccination against COVID-19 to its list of required vaccinations for individuals seeking lawful permanent resident status - colloquially known as...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
Pennsylvania business owners who are interested in applying for a COVID-19 Business Exemption Waiver, they are due April 3, 2020 at 5pm. We do not expect that this deadline will be extended....more
In a Memorandum issued this week, OFCCP has granted a three-month, national interest exemption and waiver from AAP obligations for new federal contracts “entered into specifically to provide Coronavirus relief.” In...more
CalRecycle Study Makes Recommendations to Local Agencies - The California Department of Resources Recycling and Recovery released a draft report of cost impacts to local agencies to implement Senate Bill 1383 and reduce...more
This month’s key employment law cases address meal periods and payment of wages....more
Following the U.S. decision to withdraw from the Joint Comprehensive Plan of Action (JCPOA) and reimpose sanctions on Iran, the EU has confirmed its full commitment to keep the agreement alive for the remaining parties, as...more
The Colorado General Assembly convened on January 10, 2018 for its regular session. Between now and its scheduled May 9, 2018 adjournment date, the House and Senate will consider numerous employment-related bills. Although...more
Many employers fail to fully appreciate the existence of a variety of exemptions from, or waivers of, some of California’s strict wage and hour regulations. A quick survey of common issues includes the following escape...more
On March 6, 2017, President Trump signed the highly anticipated and revised Executive Order (EO), "Protecting The Nation From Foreign Terrorist Entry Into The United States." The new order rescinds the previous EO issued at...more
The Appellate Court of Illinois (First District) recently issued an opinion clarifying how a public body can waive the Freedom of Information Act protection for predecisional records....more
On July 10, 2013, the Securities and Exchange Commission voted unanimously to adopt a “bad actor” disqualification for Rule 506 private placement offerings under Regulation D. Rule 506(d) will prevent issuers from relying on...more
On December 12, 2012, New York Attorney General Eric Schneiderman announced new proposed disclosure rules for New York-registered nonprofits designed to bring more transparency to electioneering activities by tax-exempt,...more