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Topic: Stephen M. Hahn

CDC report shows Tobacco Product Use Down Among Youths in 2020

 

U.S. Centers for Disease Control and Prevention (CDC)Atlanta, GA – A U.S. Centers for Disease Control and Prevention (CDC) report, in collaboration with the U.S. Food and Drug Administration (FDA), found that current tobacco product use declined among U.S. middle and high school students from 2019 to 2020—driven by decreases in e-cigarette, cigar, and smokeless tobacco use.

However, the National Youth Tobacco Survey (NYTS) data analysis also found that about 1 in 6 (nearly 4.5 million) students were current users of some type of tobacco product in 2020.

But nearly 4.5 million youths still used tobacco products; e-cigarette use most common

But nearly 4.5 million youths still used tobacco products; e-cigarette use most common

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FDA Coronavirus (COVID-19) Update: November 31st, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 Coronavirus pandemic.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA says Donald Trump Administration Sets Pace for Food Loss, Waste Reduction

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) announced the renewal of the joint agency formal agreement including the Winning on Reducing Food Waste Initiative.

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FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 Coronavirus. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules.

COVID-19 Coronavirus Test is authorized for individuals two years of age or older, including those not showing symptoms

COVID-19 Coronavirus Test is authorized for individuals two years of age or older, including those not showing symptoms

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FDA Statement on Vaccines, Related Biological Products Advisory Committee Meeting

 

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 Coronavirus vaccine, the U.S. Food and Drug Administration (FDA) has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – 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 Coronavirus in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Pfizer COVID-19 Vaccine Candidate

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10th, 2020 to discuss the request for emergency use authorization (EUA) of a COVID-19 Coronavirus vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 Coronavirus diagnostic test for self-testing at home and that provides rapid results.

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 Coronavirus.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: October 3rd, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA_ has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA has issued a warning letter to Nephron Pharmaceuticals Corporation (Nephron) due to emails Nephron’s CEO and a sales representative sent concerning its product Budesonide Inhalation Suspension, which were the subject of complaints submitted to the FDA Bad Ad Program.

Coronavirus

Coronavirus

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FDA Takes Actions to Help Lower U.S. Prescription Drug Prices

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – On Thursday, September 24th, 2020, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration took actions to help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.

Final Rule, Guidance Fulfill Plan for Safe Importation of Certain Drugs Originally Intended for Foreign Markets

Final Rule, Guidance Fulfill Plan for Safe Importation of Certain Drugs Originally Intended for Foreign Markets

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