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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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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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

FDA Is Hosting A Conference On CBD, Sex And Gender This Week - Marijuana Moment

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Read the full source article:  FDA Is Hosting A Conference On CBD, Sex And Gender This Week - Marijuana Moment

According to the article ...

"As the federal government continues to develop regulations around CBD, the Food and Drug Administration (FDA) will host a public conference on Thursday to highlight how the cannabinoid’s use and effects may differ based on sex and gender.

The daylong meeting, organized by FDA’s Office of Women’s Health, will include presentations on “sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation,” according to an agency description."

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What to Know About At-Home Oxygen Therapy - FDA . gov

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Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy

Giving yourself too much or too little oxygen can be dangerous. Talk with your doctor & get a prescription before buying an oxygen concentrator for use at home.

Read the full source article:  Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy - FDA.gov

According to the article:

"One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription.

You should not to use an oxygen concentrator at home unless it has been prescribed by a health care provider. Giving yourself oxygen without talking to a doctor first may do more harm than good. You may end up taking too much or too little oxygen. Deciding to use an oxygen concentrator without a prescription can lead to serious health problems such as oxygen toxicity caused by receiving too much oxygen. It can also lead to a delay in receiving treatment for serious conditions like COVID-19.

Even though oxygen makes up about 21 percent of the air around us, breathing high concentrations of oxygen may damage your lungs. On the other hand, not getting enough oxygen into the blood, a condition called hypoxia, could damage the heart, brain, and other organs.

Find out if you really need oxygen therapy by checking with your health care provider. If you do, your health care provider can determine how much oxygen you should take and for how long."

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Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

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Read the full source article:  Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

According to the article:

"Commercials for Prevagen have insisted that “it’s safe and effective,” an assurance Quincy echoed to regulators. But an investigation by WIRED now shows that for years officials at the FDA questioned the basis for the company’s claims. Multiple FDA inspections, most of which have not been reported before, found significant issues with Quincy’s manufacturing processes, complaint handling, and the quality control testing that was supposed to ensure its products were safe.

And thousands of Americans have reported experiencing “adverse events” while taking Prevagen, including seizures, strokes, heart arrhythmias, chest pain, and dizziness. While the existence of adverse event reports alone don’t prove a product is the cause, the nature and pattern of complaints about Prevagen worried FDA officials, according to agency records. One internal report from 2015 stated that the “numerous adverse events reported” indicated “a serious safety hazard.” "

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