FDA’s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements Revealed by New Guidance

In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop—and convince FDA of the safety and effectiveness of—COVID-19 vaccines, therapeutics and diagnostic tests.

To read the full text of this Duane Morris Alert, please visit the firm website.

New Jersey to Reopen Gyms and Indoor Amusement Facilities

On August 26, 2020, Governor Murphy announced the reopening of gyms and indoor amusement facilities effective as of September 1, 2020. Reopening will include a 25% of capacity limitation and typical safety protocols including masks, social distancing, one way traffic, etc.

To read the full text of this post by Duane Morris partner Brad Molotsky, please visit the Duane Morris Project Development/Infrastructure/P3 Blog.

$1B of CARES Relief for Small Business in PA Governor Wolf’s Recreational Cannabis Bill

Earlier today, August 25, 2020, Gov. Tom Wolf called on the Pennsylvania legislature to legalize recreational marijuana and use the tax revenue to help small businesses that have been impacted by the COVID-19 pandemic.

According to the Philadelphia Business Journal, Gov. Wolf’s proposal on recreational marijuana was part of a package unveiled to spend the $1 billion remaining out of $3.6 billion CARES Act funding. The Governor called for a range of spending that would include$225 million in forgivable loans and grants to small businesses and another $100 million for restaurants and bars, hospitality and leisure businesses that have taken a big hit since March with business closures and occupancy restrictions. Tax revenue from the sale of recreational marijuana would add to the state’s small business funding and half would go to historically disadvantaged businesses.

To read the full text of this post by Duane Morris partner Brad Molotsky, please visit the Duane Morris Project Development/Infrastructure/P3 Blog.

Georgia Passes Bill Limiting COVID-19-Related Liability for Businesses

Although Georgia joined several other states in urging Congress to provide a liability shield on a national level, Georgia did not wait to protect its businesses. On August 5, 2020, Governor Brian Kemp signed the Georgia COVID-19 Pandemic Business Safety Act, which took effect immediately. The act amends Georgia’s tort claims law to provide new definitions, exceptions and a presumption against liability. The act provides a general shield against liability as long as the businesses did not act with gross negligence, willful and wanton misconduct, or reckless or intentional disregard. At first glance, the law appears focused on healthcare as it applies to any “healthcare facility, healthcare provider, entity, or individual.” However, the term “entity” is defined very broadly to include most businesses.

To read the full text of this Duane Morris Alert, please visit the firm website.

Philadelphia to Lift Indoor Dining, Theater and Movie Ban

As of September 8, 2020, Philadelphia will allow indoor dining at restaurants, with restrictions. Indoor theaters and movie theaters will also be allowed to reopen on September 8 with venues not to exceed 50% capacity, with a maximum of 25 people allowed.

To read the full text of this post by Duane Morris partner Brad Molotsky, please visit the Duane Morris Project Development/Infrastructure/P3 Blog.

USCIS Issues Guidance on I-765 Employment Authorization Approval Notices for I-9 Verification amid COVID-19 Delays

Due to the extraordinary and unprecedented COVID-19 public health emergency, the production of certain Employment Authorization Documents (EADs) has been delayed. USCIS issued new guidance on August 19, 2020, authorizing employees to use Form I-797, Notice of Action, with a notice date on or after December 1, 2019, through and including August 20, 2020, stating the approval of an Application for Employment Authorization (Form I-765) as a Form I-9, Employment Eligibility Verification, List C #7 document.

To read the full text of this Duane Morris Alert, please visit the Duane Morris website.

Small Business Administration Releases Guidance on the Appeals Process for Paycheck Protection Program Loans

On August 11, 2020, the Treasury Department and Small Business Administration (SBA) released an interim final rule that details the appeals process for Paycheck Protection Program (PPP) loan borrowers for SBA loan review decisions regarding eligibility and/or forgiveness of a PPP loan. The interim final rule builds upon prior guidance released by the SBA on the review process for lenders and the SBA of PPP loans.

To read the full text of this Duane Morris Alert, please visit the firm website.

New Jersey Announces Small and Micro Business PPE Access Program

On August 11, Governor Murphy announced the first phase of the New Jersey Small and Micro Business PPE Access Program . The goal of the PPE Program is to provide small businesses and nonprofits with access to the fairly priced personal protective equipment necessary to facilitate safe working conditions during the COVID-19 pandemic.

To read the full text of this post by Duane Morris partner Brad Molotsky, please visit the Duane Morris Project Development/Infrastructure/P3 Blog.

COVID-19 Telework May Trim Fund Managers’ NYC Biz Taxes

With COVID-19 continuing to spread through much of the U.S., working from home has become the preferred, if not required, form of work for many employers and their employees. Entering the pandemic’s sixth month, this new work-life arrangement shows no signs of stopping anytime soon.

Working from home may trigger a host of unforeseen state tax consequences for employers and employees alike,[1] particularly in the Northeastern U.S. where people frequently cross state lines to travel between their office and home.

One industry in particular has seen, and may continue to see, a substantial state tax benefit from remote working arrangements: hedge fund and private equity fund managers with offices located in New York City.

To read the full text of this article by Duane Morris attorneys Scott Gluck and Maximilian Viski-Hanka, originally published in Law360, please visit the firm website.

Consolidation Of All Federal Business Interruption Cases Rejected by Judicial Panel on Multi-District Litigation

On July 31, the seven-member Judicial Panel on Multi-District Litigation (JPML) heard oral argument of extraordinary length on the potential consolidation of all federal cases involving business interruption coverage relating to COVID-19 and/or COVID-19 shutdown orders, totaling approximately 449 such federal cases, roughly 200 of which are putative class actions.

To read the full text of this post by Duane Morris partner Damon Vocke, please visit the Duane Morris Insurance Law Blog.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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