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 U.S. Department of Transportation Federal Highway Administration (FHWA) on March 7, 2024, announced a proposed rule that would discontinue its longstanding Buy America waiver for manufactured products used in FHWA-funded...more
Almost a year to the day after the Build America Buy America Act (BABA) became law, the federal Office of Management and Budget (OMB) has published its “Final Guidance for Grants and Agreements” intended to implement BABA’s...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
On August 14, 2023, the Office of Management and Budget (OMB) released a pre-publication version of final guidance implementing the Build America, Buy America Act (BABAA).The guidance adds a new Part 184 in 2 C.F.R. and...more
The Build America, Buy America Act generally requires that non-federal government infrastructure projects that benefit from federal government funding impose requirements for the use of domestic iron and steel and...more
The White House issued final guidance this week governing the procurement preferences required by the Build America, Buy America Act, or BABA, for infrastructure projects. In addition to providing definitions for key terms...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
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
On May 12, seventeen states filed a petition for review of EPA’s decision to reinstate California’s authority to set its own motor vehicle emissions standards. The petition was filed in the U.S. Court of Appeals for the D.C....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
On April 14, 2021, the Federal Communications Commission (FCC or Commission) issued an Order waiving its Section 15.255 technical and service rules for unlicensed operation in the 57-71 GHz band to permit six equipment...more
Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...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
The Mississippi Back-to-Business Liability Assurance and Health Care Emergency Response Liability Protection Act was signed into law on July 8, 2020. The Act provides sweeping immunity for businesses, health care providers,...more
Manufacturers of personal transportation and other micromobility devices—as well as providers of sharing networks for such devices—can save hundreds of thousands of dollars in litigation fees by taking proactive steps to...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
Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more
In Sheppard Mullin Richter & Hampton, LLP v. J-M Manufacturing Company, Inc., No. S232946, August 30, 2018, the California Supreme Court found that Sheppard Mullin’s failure to disclose a known conflict with another current...more
In April 2018, President Trump issued an Executive Order calling for stricter enforcement of the federal government’s “Buy American” laws. These laws have been on the books for several decades and generally require that the...more
The Oregon Bureau of Labor and Industries (BOLI) recently made a surprising change in its interpretation of the daily and weekly overtime requirements for manufacturers. Employers may be able to obtain a waiver from complying...more
Unless you are a small business regularly engaged in selling supplies to the U.S. Government, you may have only a passing familiarity with the requirements of the Non-Manufacturer Rule (NMR). The NMR is an exception to the...more
Countless ideas and inventions are developed at U.S. universities every year, often with federal funding. Many of these important ideas could not be commercialized for the public’s benefit without the Bayh-Dole Act, which...more
According to a Wisconsin state law, employers are required to provide a consecutive 24-hour rest period every 7 days for employees in factory and mercantile workplaces. As a result of the budget bill recently signed by...more
On May 28, 2015, the FCC released a Second Report and Order and Second Further Notice of Proposed Rulemaking pursuant to authority granted by the Twenty-First Century Communications and Video Accessibility Act of 2010 (CVAA)...more