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The FDA issued a warning letter jointly with the Federal Trade Commission to Avazo-Healthcare, LLC for selling adulterated and misbranded COVID-19 test kits and unapproved drug products with fraudulent COVID-19 claims. In addition to COVID-19 test kits, the company sells CBD products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19. FDA has also issued warning letters to the following companies for marketing and selling unapproved or misbranded COVID-19 products: ChromaDex; Innovative Medicine LLC; Red Moon Herbs; Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary.
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The FDA will host a webinar on the Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, as part of the series on Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use during the COVID-19 Pandemic. During this webinar, the FDA will share information about sterilizers, air purifiers, and disinfectant devices – including chemical and physical disinfectants, and ultraviolet (UV) disinfecting devices. Representatives from the FDA and the Occupational Safety and Health Administration (OSHA) will be available to answer your questions. The webinar will be Tuesday, December 8, 12 – 1 pm ET. Learn more and access the webinar.
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The CDC's Advisory Committee on Immunization Practices (ACIP) made its recommendation regarding the early distribution of a COVID-19 vaccine when it is authorized by FDA. By a vote of 13-1, ACIP recommended initial vaccinations should be offered to healthcare personnel and residents of long-term care facilities. Further considerations regarding distribution were discussed during the meeting led by Sara Oliver MD, MSPH and Kathleen Dooling MD, MPH. There PowerPoints and a link other meeting materials can be found below.
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The U.S. Food and Drug Administration (FDA) issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by healthcare personnel when there is a limited supply of respirators during the COVID-19 public health emergency.
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On Nov. 21, the FDA issued an EUA for casirivimab and imdevimab, administered together by intravenous (IV) infusion, for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. More information.
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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Learn more.
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The U.S. Food and Drug Administration (FDA) issued the Coordinated Outbreak Response and Evaluation (CORE) Investigation Table. This new tool will share information on FDA foodborne illness outbreak investigations, even in their early stages and as soon as FDA begins its response to the outbreak. It will give consumers early awareness of developing multistate outbreaks that are occurring across the United States.
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At FDA’s request, the U.S. Department of Justice filed a civil complaint in the U.S. District Court for the District of New Jersey against Natural Solutions Foundation and two individuals associated with the entity, seeking to permanently enjoin them from distributing Dr. Rima RecommendsTM Nano Silver 10PPM in interstate commerce as a prevention or treatment for COVID-19 and other diseases. The complaint alleges that Natural Solutions Foundation and the individual defendants, Dr. Rima Laibow and Ralph Fucetola, violated the Federal Food, Drug, and Cosmetic Act by unlawfully distributing a misbranded and unapproved new drug.
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FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA. The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine.
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The National Institute for Occupational Safety and Health has approved the first elastomeric half mask respirator (EHMR) without an exhalation valve. This respirator is approved for use with either P95 or P100 particulate filters (NIOSH approval numbers: TC-84A-9260, TC-84A-9261, TC-84A-9256, TC-84A-9257). This EHMR can be used for both personal protection and source control. Exhalation is accomplished through the particulate filters meeting all NIOSH requirements, thereby allowing it to also serve as a means of source control since it will maintain the high level of filtration upon exhalation. This EHMR can be cleaned and disinfected as part of a respiratory protection program’s standard procedures.
