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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FDA cGMP QSR GMP Training - online training classes offered by SkillsPlus International Inc.

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
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FAQ: What is a California Designated Representative training affidavit?

• California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. -  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses. Approved by the California State Board of Pharmacy.
  Buy now, courses for:  Wholesalers | 3PL | Reverse Distributors

Read the full source article:  What is a California Designated Representative training affidavit?

According to the article:

"The training affidavit is proof of required training.

In general, individuals applying for a designated representative license in California must submit proof that they have completed required training as specified on their applicable license application Training Affidavit form."

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• California Board of Pharmacy Designated Representative Training - online training courses by SkillsPlus International Inc. -  If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit (accepted by the Board) by taking any one of our courses. Approved by the California State Board of Pharmacy

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

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Updated April 11, 2024

The original link broke.

You might also be interested in:

Dental Amalgam Fillings - FDA.gov

---  the original post follows below  --

Read the full FDA Safety Communication:  

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

According to the communication:

"The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk to the potential adverse health effects of mercury exposure, to include:

• Pregnant women and their developing fetuses;
• Women who are planning to become pregnant;
• Nursing women and their newborns and infants;
• Children, especially those younger than six years of age;
• People with pre-existing neurological disease;
• People with impaired kidney function; and
• People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam."

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• FDA cGMP QSR GMP Training - popular online training courses by SkillsPlus International Inc.

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CA Designated Representative Training Program
California Designated Representative Training Program
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Exemptee Certification Class
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FAQ: Where can I find California Board of Pharmacy Designated Representative training courses?

Here's the answer to the FAQ:  Where can I find California Board of Pharmacy Designated Representative training?

• Wholesaler Training Course
• 3PL Training Course
• Reverse Distributor Training Course

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California Board of Pharmacy Designated Representative Training Courses (by SkillsPlus Intl Inc.)

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store