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FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees

On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more

The Connection between Gut Health, Immune Response, and COVID-19 Severity

As we have all heard, the gastrointestinal tract (gut) is full of numerous types of bacteria. Some are helpful, some are harmful. For those of us who take probiotics and/or eat fermented foods, we know that we are working...more

Implications of the Decrease in Primary Healthcare Admissions During COVID-19–Not Presenting and Surviving or Not Presenting and...

During the 2020 COVID-19 pandemic, statistics have shown a significant decline in emergency room and hospital admissions for multiple conditions, including acute coronary syndrome (ACS) (-40–50%), stroke (-30–40%), and cancer...more

Emergency Use Authorization Issued for COVID-19 Antibody

On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more

Palsgraf goes viral: Viruses as the proximate cause of an injury

A central question in every tort case is what caused the injury. The question of proximate cause does not end with the inquiry of whether it is possible for a particular product or act to cause an injury, but also whether it...more

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