Monday, December 28, 2020

FDA sends CBD warning letters to five companies - Food Business News

According to the article:

"The US Food and Drug Administration on Dec. 22 issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. The five companies illegally were marketing unapproved CBD products claiming to treat medical conditions, according to the FDA."

Read the full source article:   FDA sends CBD warning letters to five companies - Food Business News

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Saturday, December 19, 2020

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older."

Read the full news release:  FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

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Wednesday, December 16, 2020

FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA. gov

According to the news release:

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. 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. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "

Read the full news release:

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - Test is authorized for individuals two years of age or older, including those not showing symptoms - FDA.gov


Saturday, December 12, 2020

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine - FDA .gov

According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

"The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide."

Read the full news release: FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine -  FDA.gov

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Wednesday, December 9, 2020

Millions of Americans receive drugs by mail. But are they safe? - NBC News

 According to the article:

"Millions of Americans receive their medications by mail but many, like Becker, find themselves forced to do so by their insurance plans or face the prospect of paying exorbitant amounts for the same drugs. 

An NBC News investigation found the growth of mail-order pharmacies has caused many people to feel trapped in a system that has left them with crushed pills, damaged vials and lifesaving drugs exposed to extreme weather.  ...

Interviews with more than 65 mail-order pharmacy customers across the nation revealed deep worries over how their medication is delivered — and no affordable alternatives. Many reported receiving drugs in flimsy packaging without temperature indicators, which can cost as little as a dollar per package. Others have had to plead with pharmacies to send them replacement drugs after receiving medication they thought arrived too warm or cold."

Read the full source article:  Millions of Americans receive drugs by mail. But are they safe? - NBC News

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