FDA Provides Two New Guidances for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19

On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products” and “COVID-19: Developing Drugs and Biological Products for Treatment of Prevention,” provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.

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

USCIS Premium Processing, Suspended for COVID-19, Returns for Nonimmigrant and Worker Visa Petitions

On May 29, 2020, USCIS announced that it will resume premium processing for Form I-129 petitions for nonimmigrant workers and Form I-140 immigrant visa petitions in phases over the next month. USCIS had suspended premium processing on March 20, 2020, partially in response to the COVID-19 pandemic.

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

Duane Morris Chicago Office Provides Meals for Healthcare Heroes

On Friday, May 29, Duane Morris’ Chicago office provided meals to healthcare workers on the front lines at Saint Anthony Hospital. This is part of our firm wide initiative Meals for Healthcare Heroes. This program is funded by donations from Duane Morris attorneys and staff and is meant to honor and support the Healthcare workers and support local restaurants. On-site delivery from Wishbone Chicago included Duane Morris employees Jamie Brown and Sally Wagner. This is the first of fifteen Meals for Healthcare Heroes events Duane Morris’ COVID-19 Strategy Team will be hosting nationwide.

Delivery

CDC Provides Guidance on COVID-19 Antibody Testing

On May 26, 2020, the Centers for Disease Control and Prevention issued interim guidelines for COVID-19 antibody testing in clinical and public health laboratories. The guidelines contain recommendations for clinical and public health laboratories regarding: choice of test and testing strategy; individuals who test positive for COVID-19 antibodies; and additional considerations on the use of antibody tests.

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

The New World of Foreign Direct Investment in Europe During the COVID-19 Era

Notwithstanding the multi-layered measures taken by national governments to support their respective economies, the COVID-19 pandemic is threating the existence of an increasing number of businesses of all sizes.

As economies start to emerge from lockdown, many businesses will urgently need to look for sources of liquidity, whether in the form of debt or equity. This will create opportunities for both existing and new investors, particularly those that can transact quickly.

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

Paycheck Protection Flexibility Act passed by U.S. House of Representatives

The new Paycheck Protection Flexibility Act (H.R. 7010), which focuses on small businesses and restaurants in particular, has passed the U.S. House of Representatives.

The bipartisan Paycheck Protection Flexibility Act,was introduced last week by Reps. Dean Phillips, D-Minnesota and Chip Roy, R-Texas, and is designed to extend the 8-week period under which loan recipients could spend PPP money to 24 weeks while helping correct other provisions that would provide more flexibility to small businesses in the hospitality realm.

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