Two New Guidances from FDA 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.

Depositions During the COVID-19 Crisis

With 95% of the country presently subject to stay-at home orders due to COVID-19, many litigators are considering whether and how to take depositions in the coming weeks. Federal court responses have varied, from blanket extensions of civil deadlines to encouraging remote depositions. Whether it is advisable or even permissible to depose a witness under current circumstances will depend on several factors, including the jurisdiction, the deponent, and the anticipated substance of the deposition.

Many Courts are Extending Discovery Deadlines:

Numerous courts have issued administrative orders extending all civil deadlines due to COVID-19. The District of New Jersey, for example, in Standing Order 2020-04, extended all filing and discovery deadlines which fall between March 25, 2020 and April 30, 2020 by forty-five days. See also, Standing Order 3:20-mc-105 (D.S.C. Mar. 16, 2020) (extending all civil deadlines); Standing Order 20-0012 (N.D. Ill. Mar. 30, 2020) (same).

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Personal Protective Devices Available Through 3D Printing Process

During the COVID-19 pandemic, the demand for personal protective equipment (PPE) has significantly outpaced the capabilities of the traditional supply chain. Gowns, gloves, facemasks, and face shields are valued commodities that even many healthcare providers cannot secure in this environment. While traditional supply and manufacturing chains struggle to keep up with production, industry leaders have turned to 3D printing, or additive manufacturing technology, to address this dire need. Unlike traditional manufacturing methods, companies with already established additive manufacturing technologies can more readily and efficiently adapt their productions to manufacture such PPE. 3D printing manufacturers may already have the powder or fabric necessary to manufacture PPE. They also have versatile printers. These companies simply need software and product design specifications, which allows them to begin production much more quickly than companies relying on traditional manufacturing methods that require additional raw materials and even machines and equipment.

For example, Superfeet, a shoe insert manufacturer, which typically uses 3D printing for manufacturing its products, was contacted about its ability to assist with a shortage of powered air purifying respirators (PAPR) hoods to hospitals in Washington state. The company had printers and fabric already. In just a few short days, Superfeet was making PPE.

To read the full text of the article by Duane Morris , visit the MD+DI website.