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
...The main issue seems to relate to the number of parking spaces required, proposed, and provided. While most developers and builders seek flexibility to provide parking in accordance with industry trends or neighborhood...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
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
More than a year has passed since Congress enacted the Build America, Buy America Act (“BABA”)—a sweeping change to domestic sourcing requirements for federally funded infrastructure projects. BABA, which was included as part...more
The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more
The American Institute of Architects (AIA) Contract Documents program recently released a limited number of state-specific Sworn Construction Statements and Lien Waiver and Release forms for use on construction projects. At...more
Republican-appointee Commissioners Roisman and Peirce issued a statement on February 12 publicly disagreeing with Acting Chair Lee’s recent fiat discontinuing the Enforcement Division’s practice of proposing settlements that...more
On January 11, 2021, the Centers for Medicare & Medicaid Services (CMS) released a new web portal to more easily permit healthcare providers and other stakeholders to submit requests for specific waivers of certain healthcare...more
FERC has issued an order extending the blanket waivers of all requirements to hold meetings in person and/or to provide or obtain notarized documents in open-access transmission tariffs through January 29, 2021....more
HCCA has assembled a half-day virtual conference to help compliance professionals stay on top of the fast-moving changes caused by the COVID-19 pandemic. By participating in this event, you will hear directly from the...more
On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other...more
Nelson Mullins white collar attorneys Gabriel Imperato, Lester Perling, and Mike Ruggio will discuss the potential liabilities and whistleblower risks associated with application, certification, and receipt of COVID-19...more
California Governor Gavin Newsom’s March 30th Executive Order authorized the Department of Consumer Affairs to issue waivers of certain laws and regulations pertaining to healthcare licensees. On April 14th, the Department of...more
On March 30, 2020, the Ohio Bureau of Workers’ Compensation (BWC) announced that it is waiving all safety education and training requirements for the following programs...more
On March 20, 2020, Georgia Governor Brian Kemp issued an Executive Order "Reducing Regulations to Assist the State's Response to the Spread of COVID-19" (the Order). The purpose of the Order is to reduce "certain restrictions...more
The German government seeks to promote the prospering of the German economy as finding skilled employees from the German labour market becomes more difficult for many employers, especially in the industries of nursing care...more
Changes to Proposed Regulations Could Impact Local Agencies that Collect or Generate Organic Waste - The California Department of Resources Recycling and Recovery released its second set of revisions to the proposed...more
Certain “bad actors” who settle with the SEC may be subject to automatic disqualifications or collateral consequences under federal securities laws and regulations. The Commission, however, may grant a settling party’s...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
On April 18, 2019, the Federal Energy Regulatory Commission (FERC) granted Sunrun, Inc. (Sunrun) limited waivers of FERC’s filing requirements for obtaining qualifying small power production facility (QF) status under the...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
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations...more