Editor's Note The Food and Drug Administration’s (FDA’s) Office of Biostatistics and Epidemiology is currently developing master protocols to be used in monitoring the safety and effectiveness of a COVID-19 vaccine once it is authorized or approved, in addition to postmarket surveillance requirements, the October 22 Regulatory Focus reports. The…

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Editor's Note ECRI announced October 21 that its President and CEO, Marcus Schabacker, MD, PhD, will tell the Food & Drug Administration Vaccines and Related Biological Products Advisory Committee on October 22 that a thorough review of 6 months of completed clinical trial data for COVID-19 vaccines is needed to…

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Editor's Note The Food and Drug Administration (FDA) on October 15 announced that it reissued the Emergency Use Authorization (EUA) for certain N95 and other filtering face-piece respirators that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety…

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Editor's Note The Food and Drug Administration (FDA) on October 6 released guidance on the data and information needed to support the issuance of emergency use authorization (EUA) for COVID-19 vaccines. The recommended data and information include: chemistry, manufacturing, and controls information clinical and nonclinical data and information administration and…

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Editor's Note Secretary of Health and Human Services (HHS), Alex Azar, on October 2, renewed the national public health emergency (PHE) for COVID-19 for another 90 days. The renewal will take effect October 23. This is the third renewal of PHE, which has been in effect since late January. The…

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Editor's Note The Food & Drug Administration (FDA) on August 27 (updated September 2) issued a warning about alcohol-based hand sanitizers packaged in containers that may appear as food or drinks and could put consumers at risk of serious injury or death if ingested.( https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-warns-consumers-about-hand-sanitizer-packaged-food-and-drink-containers ) Some hand sanitizers are…

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Editor's Note The US Department of Health and Human Services (HHS) and Department of Defense (DOD) on September 16 released two documents outlining a detailed strategy for delivering safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible. The documents, which were developed in…

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Editor's Note Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health told the Kaiser Health News on September 1 that a COVID-19 vaccine could be available earlier than expected if clinical trial results are overwhelmingly positive. An independent Data and…

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Editor's Note In an interview with the Financial Times, Food & Drug Administration (FDA) Commissioner Stephen Hahn, MD, on August 30, said the FDA could fast-track approval of a COVID-19 vaccine before late-stage clinical trials are complete if regulators believe the benefits of doing so outweigh the risks. Dr Hahn…

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Editor's Note In an August 21 letter, the Food & Drug Administration (FDA) warns that the use of passive protective barrier enclosures without negative pressure when treating patients (such as during intubation, extubation) who are known or suspected to have COVID-19 may pose increased health risk to patients and healthcare…

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