FDA Virtual Town Hall for Laboratories and Manufacturers Developing Diagnostics Tests for COVID-19

FDA is hosting a virtual town hall April 1, 2020, at 12:15 p.m. Eastern for clinical laboratories and commercial manufacturers developing diagnostic tests for the COVID-19 virus. FDA intends to help answer technical questions about validation and development of tests and FDA’s recently issued Guidance from March 16, 2020 outlining FDA policy for development of diagnostic tests during the COVID-19 public health emergency.  FDA will host subsequent virtual town halls for clinical laboratories and commercial manufacturers each Wednesday of April at 12:15 p.m. Eastern. Registration not required. Details to join the call are available on the event page.

For additional information, please contact Dana J. AshFrederick R. BallPatrick C. Gallagher, Ph.D.Jonathan LourieVicki G. Norton, Ph.D., or Sandra G. Stoneman of Duane Morris’ LIfe Sciences Industry Group.

Florida Governor Issues Stay-at-Home Order—But Only for Southeast Florida

On March 30, 2020, the Office of the Governor of the State of Florida issued Executive Order 20-89, the most recent step taken by Governor Ron DeSantis to deal with the spread of COVID-19 throughout Florida. The order essentially directs the counties comprising South Florida (and neighboring Monroe County) to restrict public access to nonessential businesses and facilities until at least April 15, 2020. While other states adopting “stay-at-home” orders have done so on a statewide basis, this order is limited to four counties in southeast Florida. Despite calls for the governor of the country’s third-most populous state to implement the restrictions across the state, he has not done so—yet.

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

The CARES Act Amends Federal Law Governing the Confidentiality of Substance Use Disorder Patient Records

The CARES Act, enacted on March 27, 2020, makes notable changes to federal law governing the disclosure of substance use disorder records.  The Act amends 42 U.S.C. 290dd-2, the governing statute of the regulations at 42 C.F.R. Part 2 to better align certain of its confidentiality requirements with HIPAA.

To read the full text of this post by Duane Morris attorney Melissa Sobel Snyder, please visit the Duane Morris Health Law Blog.

New COVID-19 UK Government Financing Options Available

The UK government recently announced a package of measures to provide liquidity to UK businesses during the COVID-19 pandemic. Two schemes are particularly useful for financing needs: the HM Treasury and the Bank of England COVID-19 Corporate Financing Facility and the British Business Bank Coronavirus Business Interruption Loan Scheme.

To read the full text of this Duane Morris Alert, which  provides summaries of the financing schemes, eligibility requirements and the application process, please visit the firm website.

Federal Prosecutors Begin Charging COVID-19 Fraud in California and New Jersey

By Jovalin Dedaj

Yesterday, federal prosecutors in the District of New Jersey charged a Georgia man for his alleged role in a conspiracy to defraud federally funded and private health care benefit programs by submitting fraudulent testing claims for COVID-19 and genetic cancer screenings.   It follows a criminal complaint announced last week by the U.S. Attorney’s Office for the Central District of California against a Southern California man on a federal fraud charge alleging he solicited investments in a company he claimed would be used to market pills that would prevent coronavirus infections and an injectable cure for those already suffering from COVID-19.  These cases are among the first criminal actions in the ongoing public health crisis and come on the heels of the first civil enforcement action by the Department of Justice against a COVID-19 related fraud.

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Annual Meetings When Your Stockholders Cannot Actually Meet

Millions of stockholders of Delaware corporations are currently under some form of “stay-at-home” restrictions, and applicable guidelines from health officials limit gatherings to no more than 5-10 people, each of which have to be at least 6 feet away from one another.  These safety protocols, while necessary, make it essentially impossible to convene annual stockholders’ meetings as has been traditional–in person.

To read the full text of this post by Duane Morris partner Richard Renck, please visit the Duane Morris Delaware Business Law Blog.

USTR Offers New Section 301 Exclusions for COVID-19 Medical Products

Since our previous two Alerts, on March 13 and 20, describing actions taken in recent weeks by the U.S. Trade Representative (USTR) to exclude numerous medical products imported from China from Section 301 tariffs, the USTR has announced it will accept new Section 301 exclusion requests relating to other products that can be used in the battle against the coronavirus (COVID-19). Such exclusion requests can be submitted for any product that can be used to address the COVID-19 pandemic that has not yet been granted by the USTR, including products with previously denied or currently pending exclusion requests, as well as for products for which requests have not been filed.

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

Maryland Provides Economic Relief from COVID-19 for Businesses and Tax Payers

In response to the COVID-19 pandemic, federal, state and local governments are ushering in an array of programs and tax relief measures to help mitigate the adverse economic impact of COVID-19 on business and nonprofit entities.

In addition to the economic incentive provisions and programs that are available through the new federal CARES Act, including the $350 billion Paycheck Protection Program (PPP) and the U.S. Small Business Administration’s (SBA) Emergency Injury Disaster Loan (EIDL) program, Maryland has offered a number of new economic assistance programs, tax relief measures and deadline extensions to help businesses and individuals impacted by the COVID-19 pandemic.

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

COVID-19 Guidance for Employers in Vietnam

Employers the world over are facing unprecedented issues brought about by the COVID-19 pandemic. Vietnam employers are no different. They need to be able to both respond rapidly and decisively to actual facts and formal and information government direction as it arises and simultaneously comply with legal obligations set out in law and statute. What trumps what?

To read the full post from Duane Morris Vietnam partner Giles Cooper, please visit the Duane Morris Vietnam Blog.

CARES Act Impacts Banking and Finance Industry

The Coronavirus Aid, Relief and Economic Security (CARES) Act includes wide-ranging provisions that will have direct and indirect impacts on the banking and finance industry.

The unprecedented $2 trillion stimulus package includes, among other things, provisions for the removal of the cap on the FDIC’s guarantee of insured deposits; waiver by the OCC of single-borrower lending limits for national banks; reduction of the minimum leverage ratio for community banks; favorable accounting treatment for loan modifications; and authority for a guarantee program for the U.S. money market mutual fund industry.

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

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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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