On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker...more
What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older....more
The U.S. Food and Drug Administration (FDA) has continued to publish food safety updates relating to the coronavirus (COVID-19) pandemic throughout the pandemic. Foley’s Food and Beverage team have continued to monitor and...more
The U.S. Food and Drug Administration (“FDA”) in March 2020 temporarily halted its domestic inspection program amid the coronavirus disease (COVID-19) pandemic. During this time, FDA continued to use other tools, including...more
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
On Sunday, April 26th, the Centers for Disease Control and Prevention (CDC) and the Department of Labor (DOL) issued interim guidance specific to the meat and poultry processing industry to facilitate ongoing operations and...more
In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more
4/7/2020
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Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Personal Protective Equipment ,
Prescription Drugs
The spread of COVID-19 has led to questions for the food industry regarding the food supply chain, FDA’s role in protecting it, and changes to FDA operational procedures during the public health emergency. In response, FDA...more
3/20/2020
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Coronavirus/COVID-19 ,
Department of Homeland Security (DHS) ,
FEMA ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
FSMA ,
FSVP ,
Public Health ,
Public Health Emergency ,
Supply Chain ,
World Health Organization
...The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has been documented in six of the world’s seven continents (sparing only Antarctica), in more than 70 countries and territories. More...more
3/6/2020
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Business Continuity Plans ,
Business Interruption ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Force Majeure Clause ,
Imports ,
Infectious Diseases ,
Material Adverse Change Clauses (MACs) ,
OSHA ,
Performance Standards ,
Public Health ,
Risk Management ,
Suppliers ,
Supply Chain ,
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World Health Organization