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FDA Approves First COVID-19 Test for Sample Pooling

On July 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for sample pooling of specimens when using the SARS-CoV-2 rRT-PCR diagnostic test from Quest Diagnostics....more

Got More Hand Sanitizer? (Part 2) More Legal and Business Considerations for New Market Entrants

This second McGuireWoods alert discussing regulation of hand sanitizer manufacture and distribution addresses new considerations from the Food and Drug Administration (FDA) published in a June 2020 update to its March 2020...more

One of These Things Is Not Like the Others: FDA Flexibility With Food Ingredients During COVID-19

During the COVID-19 pandemic and national emergency, the U.S. Food and Drug Administration (FDA) has taken a relatively relaxed approach to some of the more concrete regulations governing the nation’s food supply. This month,...more

Executive Order Requires Continued Operation of Meat and Poultry Industries

On April 28, 2020, President Trump invoked powers under the Defense Production Act of 1950 (50 U.S.C. 4501 et seq.), finding that COVID-19 has significantly disrupted the food supply chain with regard to the meat and poultry...more

Pharmacy Developments Related to COVID-19 Testing and Compounding of Critical Drugs

COVID-19 has forced the healthcare system to adapt to a unique set of circumstances. As reported in prior McGuireWoods updates, a number of state and federal developments have affected the practice of pharmacy during the...more

Some States Relax Regulation of Medical and Recreational Cannabis During COVID-19 Crisis

Amid a sea of regulatory changes occurring in response to the novel coronavirus (COVID-19) pandemic, several states have temporarily suspended cannabis regulation to enhance consumer access to cannabis products during the...more

FDA Suspends Some Restrictions to Facilitate Veterinary Telemedicine Amid COVID-19 Crisis

To provide relief during the coronavirus (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) announced on March 24, 2020, that it will not enforce certain veterinarian-client patient relationship (VCPR)...more

CARES Act Modernizes Over-The-Counter Drug Monograph Process

A complete overhaul to the over-the-counter (OTC) drug system quietly rode its way into law with the Coronavirus Aid, Relief, and Economic Security Act or the CARES Act (H.R. 748), along with several other significant reform...more

State Boards Ease Regulations For Pharmacy Practitioners During COVID-19 Pandemic

As states brace themselves for an increasing number of novel coronavirus (COVID-19) cases, some pharmacy boards have relaxed regulations to ease burdens on pharmacy practitioners. Several states have declared a state of...more

Due to COVID-19, Federal Agencies Reduce Barriers to Controlled Substances and Increase Access to Care

The unprecedented public health emergency created by the novel coronavirus disease (COVID-19) has sparked action by state and federal regulators to ensure greater access to care, while simultaneously limiting the spread of...more

Got Hand Sanitizer? Business and Legal Considerations for New Market Entrants

With the COVID-19 pandemic, the demand for hand sanitizer is extremely high, and the supply chain has not kept pace with that demand. In an effort to meet public need, several federal agencies, including the Food and Drug...more

Pharmacists Urged to Curtail Off-Label Prescribing for Experimental COVID-19 Treatments

Pharmacies nationwide are struggling to keep up with the demand for new prescriptions of hydroxychloroquine, chloroquine and mefloquine, the decades-old immunosuppressant and/or anti-inflammatory agents used for treating...more

FDA’s Emergency Use Authorization Process for COVID-19 Tests May Alleviate Shortage

As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more

FDA Changes Position on Clinical Trials and Respirators During COVID-19 Crisis

In light of the urgent need for medical intervention during the coronavirus pandemic, the Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control...more

FDA’s Dual Approach to Enforcing Federal Food, Drug, and Cosmetics Act During COVID-19 Crisis

The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements...more

Countermeasures and Why They Matter for Liability During COVID-19

Under the Public Readiness and Emergency Preparedness Act, the secretary of the U.S. Department of Health and Human Services can issue a declaration to provide immunity for individuals and entities from any liability arising...more

Food Safety During COVID-19 Pandemic: FDA to Relax Some Requirements, USDA Inspections Continue

During the COVID-19 (coronavirus) national emergency, the Food and Drug Administration and U.S. Department of Agriculture continue to emphasize measures intended to keep the food supply safe....more

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