FDA

On Wednesday, May 7, 2021, the United States officially endorsed waiving intellectual property protections for COVID-19 vaccines. While the United States has taken the opposite position in recent months, the administration asserts that its departure is guided, at least in part, by the goal “to get as many safe and effective vaccines to as many

On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19.  According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered

N.B.  Concurrent with the posting of this article, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (“FDA”) has decided to recommend to the FDA that the FDA approve the emergency use authorization applications submitted by Pfizer and BioNTech.  It is being reportedd that the FDA may formally approve the

Even two weeks after Election Day, jurisdictions nationwide are riding high after a number of positive wins related to the possible systemic legalization of cannabis use nationwide.  As of November 3, 2020, the pendulum now undeniably swings in favor of cannabis, with medical cannabis legal in 33 states and recreational adult-use permitted in 12 states

This week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for Disease Control and Prevention and U.S. Department of Health and Human Services testified on Capitol Hill on the federal response

It would be an understatement to say that the COVID-19 pandemic impacted transactional activity for buyers and sellers across a range of industries, the hemp and cannabis merger and acquisition (“M&A”) space being no exception.  In particular, the current period of COVID-19 volatility in the hemp and cannabis space is marked by numerous consequential outcomes,

As the novel coronavirus (COVID or COVID-19) continues to ravage the United States, the cannabis industry is feeling the pandemic’s negative impacts despite an initial spike in sales after cannabis operations were deemed essential under various state “stay-at-home” orders.[1]  This article details the most recent state-level responses activated in California and Illinois.
California

FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including performing risk assessments to determine whether the virus poses new risks to drug products, or to the manufacturing facilities or processes that produce them.  FDA is

The US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19.  The Agency has articulated its guidelines for PPE in one of two ways: (1) through guidance documents and (2) through issuance of “umbrella” Emergency Use Authorizations (EUAs) that cover certain product types.  EUAs

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational

Many Illinois cannabis contracts, including intellectual property licensing agreements, development agreements and supply agreements, contain force majeure clauses.  Depending upon the language of these clauses, the COVID-19 pandemic may be an event that triggers these clauses and provides a defense to nonperformance of the contract.
Companies that are experiencing difficulties complying with or enforcing compliance

This article originally appeared in Law360 on April 13.

The Public Readiness and Emergency Preparedness Act, along with the declaration by the U.S. Department of Health and Human Services on countermeasures against COVID-19, provide hospital systems with broad liability protections for measures taken in response to the pandemic.

There are limitations, however, to immunity under