Dean Fanelli

Dean Fanelli

Seyfarth Shaw LLP

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FDA Issues Emergency Use Authorization for COVID-19 Vaccine

On December 11, 2020, FDA issued the first emergency use authorization (“EUA”) for a vaccine to prevent COVID-19. The vaccine, developed by Pfizer-BioNTech, is authorized for those 16 years of age and older....more

12/15/2020  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Pfizer , Public Health Emergency , Vaccinations

FDA Revokes Emergency Use Authorization For Highly Watched Chloroquine and Hydroxychloroquine - But They Can Still Be Prescribed

FDA recently revoked a multi-month Emergency Use Authorization (the EUA) for use of chloroquine and hydroxychloroquine as an experimental treatment for patients suffering from COVID-19. ...more

6/22/2020  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Medical Supplies , Pharmaceutical Industry , Prescription Drugs

FDA Revises Guidance on Face Masks, Respirators, and Face Shields to Address Covid-19 Concerns

Earlier last week, the US Food and Drug Administration (FDA) issued new and revised guidance on its enforcement policy for face masks, surgical masks, respirators, and face shields during the COVID-19 emergency in response to...more

6/1/2020  /  Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Health Care Providers , Healthcare Workers , Life Sciences , NIOSH , Personal Protective Equipment , Workplace Decontamination

FDA Updates Emergency Use Authorization For Chinese Respirators

Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...more

5/8/2020  /  China , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Imports , Life Sciences , Medical Devices , Medical Supplies , NIOSH , Personal Protective Equipment , Pharmaceutical Industry

FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more

4/17/2020  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Guidance Update , Laboratory Developed Tests , Legislative Agendas , Proposed Legislation , Public Health Service Act , Regulatory Oversight

FDA Emergency Use Authorizations (“EUA”) for COVID-19: What is an EUA and What is Currently Covered?

Starting in February 2020, the US Food and Drug Administration (the “FDA”) began using its Emergency Use Authorization (“EUA”) powers under Section 564 of the Federal Food, Drug, and Cosmetic Act (“FD&C”) to allow unapproved...more

4/2/2020  /  3D Printing , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Medical Supplies , Personal Protective Equipment , Pharmaceutical Industry , Prescription Drugs
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