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April 1, 2020, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

April 1, 2020, Covington Alert

The Coronavirus Aid, Relief, and Economic Security (CARES) Act opens up new Small Business Administration (SBA) loan opportunities to support many companies and nonprofit organizations with 500 or fewer employees.

April 1, 2020, Covington Alert

The scope and scale of recent events is almost inconceivable. All of us —including the Committee on Foreign Investment in the United States (“CFIUS”) — are sailing in uncharted waters. That said, while we may not have all of the answers, we are able to share some insights from the CFIUS front lines regarding how the challenges presented by the COVID-19 pandemic ...

March 31, 2020, Covington Alert

On March 30, 2020, the inspectors general of several major agencies selected the Department of Defense Inspector General, Glenn Fine, to lead a newly created federal oversight entity that will investigate waste, fraud, and abuse in connection with the massive new coronavirus economic relief legislation. The inspectors general were exercising new authority ...

March 30, 2020, Covington Alert

On Friday, March 27, 2020, FDA’s Center for Veterinary Medicine (CVM) issued a Fact Sheet on “Safely Distributing Unused Human Food for Animal Food Use During COVID-19.” The advisory accompanying the Fact Sheet explains that because of COVID-19-associated restrictions on in-store dining, certain businesses may have surplus food that, if not usable for human ...

March 30, 2020, Covington Alert

Since the last financial crisis, the commercial real estate industry has accumulated vast amounts of debt. By one account, there is currently more than $3.6 trillion in mortgage debt secured by commercial and multi-family residential properties. Much of this debt is held by real estate investment trusts (“REITs”), in the form of commercial mortgage-backed ...

March 30, 2020, Covington Alert

On Friday, March 27, 2020, the U.S. Food and Drug Administration (FDA) released updated guidance to ensure that drug manufacturers notify FDA as soon as possible of potential interruptions in manufacturing that could lead to drug shortages. The Guidance, titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of ...

March 30, 2020, Covington Alert

On March 28, 2020, the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) updated its March 19, 2020 “Essential Critical Infrastructure Workforce” advisory list. These updates largely focus on clarifying which workers CISA considers to be essential, which may be helpful for the human and animal food industries. At the same ...

March 29, 2020, Covington Alert

Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other ...