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

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.
• California HMDR Exemptee Online Training Certification Course

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."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

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 

Do Not Use Infant Sleep Positioners Due to the Risk of Suffocation - FDA Consumer Updates

Learn more:  Consumer Updates > Do Not Use Infant Sleep Positioners Due to the Risk of Suffocation:

"The U.S. Food and Drug Administration is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death.

The two most common types of sleep positioners feature raised supports or pillows (called “bolsters”) that are attached to each side of a mat, or a wedge to raise a baby’s head. The positioners are intended to keep a baby in a specific position while sleeping and are intended for infants under 6 months old."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Consumer expenditure on FDA regulated products: 20 cents of every dollar

• Trusted FDA GMP online training programs and courses taught by SkillsPlus International Inc.

Updated May 9, 2022

The original link broke. 

You can still read about the same topic here:

Consumer expenditure on FDA regulated products: 20 cents of every dollar - MassDevice.com

---  the original post follows below  ---

Read the full article:  Consumer expenditure on FDA regulated products: 20 cents of every dollar | FDA Voice:

"One of the much-cited statistics about FDA is this: that FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers. Add up 20 cents of every dollar and it amounts to more than $2.4 trillion in annual consumption that includes medical products, food and tobacco."

'via Blog this'

The FDA sure has a broad economic reach!

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

FDA cGMP QSR GMP Training

FDA cGMP QSR GMP Training

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation

Read the full article: Ancestry.com In Talks With FDA To Offer Genetic Testing | Fast Company | Business + Innovation:

"Ancestry.com, the popular genealogy site, is talking to the FDA about using DNA to estimate disease risk for the company’s member base. CEO Tim Sullivan revealed the news in an interview with The Verge, effectively announcing his company’s intention to eventually offer straight-to-consumer genetic testing.

Ancestry is currently in the "very early stages of a conversation with the FDA," Sullivan told The Verge. "We think it's totally appropriate that the FDA has stepped in to pretty aggressively regulate direct-to-consumer genetic tests—and we're just starting from that perspective, and trying to work very closely with them," he continued."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Says - Use Sunscreen Spray? Avoid Open Flame

• Respected FDA CGMP online training courses provided by SkillsPlus International Inc.

Updated July 28, 2021

The original link broke.

You can still read about this topic here:

FDA reminds consumers spray-on sunscreens can catch fire - CBS News

---  the original post follows below  ---

Consumer Updates > Use Sunscreen Spray? Avoid Open Flame:

"You love a good summer barbecue and wisely use sunscreen if you are out in the sun. What you may not know is that if you apply certain sunscreen sprays and then come close to a source of flame, you may risk the sunscreen catching fire and giving you a serious burn.

The Food and Drug Administration (FDA) has become aware of five separate incidents in which people wearing sunscreen spray near sources of flame suffered significant burns that required medical treatment."

Follow this link to more FDA Sunscreen resources and information

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Fireworks Safety & Injuries - Be Safe!

Take caution with fireworks!

Fireworks injuries sent more than 5,000 people to U.S. emergency departments in the 30 days surrounding the Fourth of July last year, with firecrackers, aerial explosives and homemade devices causing most of the harm, consumer safety experts said. About 60 percent of the estimated 8,700 people treated for injuries in 2012 were hurt between June 22 and July 22, according to new figures from the U.S. Consumer Product Safety Commission.

Follow the link below to view the US CPSC Fireworks injuries infographic.

CPSC Science: Fireworks Injuries 2013 Update | OnSafety:

"Back after high demand last year, we have an updated version of our Fireworks Injuries infographic."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Free Tips - Don't Fall for Health Fraud Scams

• Trusted and respected FDA GMP online training courses, programs, and classes offered by SkillsPlus International Inc.

Consumer Updates > 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams:

"In this video, FDA Commissioner Margaret A. Hamburg, M.D., and FDA National Health Fraud Coordinator Gary Coody, R.Ph., discuss health fraud and tips for avoiding scams."

[embedded video removed]

'via Blog this'

Learn more about health fraud scams from the FDA:  Health Fraud Scams (FDA)
"Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment. They can also cause serious or even fatal injuries."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

• 
  

Knock, Knock, FDA Calling

This is a nice article with a nutritional supplement twist to it.

Knock, Knock, FDA Calling - Slowtwitch.com:

"In the United States, the Food and Drug Administration (FDA) is responsible for protecting and promoting public health with ultimate oversight of food and drugs, and of particular interest for this article, the nutritional supplement industry. Their regulatory control covers two main areas: product safety and accurate product labeling. This article summarizes some of what goes on behind the scenes to keep consumer products safer."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog

Related articles

• 2012 Onsite cGMP & QSR Compliance Courses by SkillsPlus Intl Inc. (skillsplusinfo.blogspot.com)
• Live Onsite GMP Training - Olympics for Pharma & Biotech Manufacturers (skillsplusinfo.blogspot.com)
• Gluten in Drug Products - FDA Request for Info (drughealth.blogspot.com)

FDA issues first social media rules for drug companies

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again. 

The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."

'via Blog this'

Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• Should Mobile Medical Apps Require FDA Approval? (drughealth.blogspot.com)

NIH Complementary and Alternative Medicine Website

Image via Wikipedia

From the NIH (National Institutes of Health): 

NCCAM's (National Center for Complementary and Alternative Medicine) Time to Talk campaign encourages patients to tell their providers about CAM (complementary and alternative medicine) use and providers to ask about it by offering tools and resources — such as wallet cards, posters, and tip sheets — all of which are available for free at:   http://nccam.nih.gov/timetotalk/

More information for providers:  http://nccam.nih.gov/health/providers/.

Return Home: http://drughealth.blogspot.com/

FDA Launches Website Explaining Food and Drug Regulations

It's a new year, and it's time to think about professional development goals for 2011.  You or your friends, family, or staff, might want to consider learning some of these FDA Basics:

FDA Basics for Industry  or
FDA Basics - Provides Information About FDA and What the Agency Does

Return Home: http://drughealth.blogspot.com/

You Eat Too Much Salt!!!!

People, stop eating so much salt, says this CDC post, "Americans Consume Too Much Salt - Lower sodium recommendation applies to almost 70 percent of American adults." Here's what you need to know . . . This study is the first to use national data to show that 69.2 percent of the adult population belongs to a specific group that should aim to consume no more than 1,500 mg of sodium per day. This group includes persons with high blood pressure, blacks, or middle-aged and older adults (more than 40 years old). The 2005 Dietary Guidelines for Americans recommend that adults in general should consume less than 2,300 mg (approximately one teaspoon of salt) of sodium per day. Can you cut back on your salt?! 

Return Home: http://drughealth.blogspot.com/ 

New AHRQ Website On Emerging Issues In Medical Therapeutics

Updated January 30, 2021

People are also interested in:

HCA data consortium with AHRQ and others seeks to speed COVID-19 research (HealthcareITnews) - Johns Hopkins, Duke, Meharry Medical College, Harvard Pilgrim and others will gain access to HCA's data registry to help boost patient outcomes and improve public health.

- - -  original post follows below  - - -

The Agency for Healthcare Research and Quality (AHRQ) announced a new educational website that offers expert perspectives, advice and guidance on drugs, biological products and medical devices from the AHRQ's Centers for Education and Research on Therapeutics (CERTs), a federally sponsored network of more than a dozen leading research centers nationwide. The new website, Clinician-Consumer Health Advisory Information Network (CHAIN) links clinicians and consumers with therapeutics information to assist in clinical practice and health care decisionmaking in areas where evidence is undergoing significant and rapid changes. This site will be of interest to manufacturers because of the touchpoints with clinicians, consumers, drugs, biologics, and medical devices, and CERT consultation and collaboration with the FDA. What do you think about the new site? Is it useful for your purposes? 

Return Home: http://drughealth.blogspot.com/

FDA Struggles To Keep Products From Foreign Sources Safe

• Trusted FDA GMP online training courses and programs taught by SkillsPlus International Inc.

This is required reading for consumers, and for professionals working in the GXP regulated industries (obtaining supplies, food, drugs, etc. from foreign suppliers). Gardiner Harris, a correspondent in The New York Times’s Washington bureau, writes about the very dangers and risk that are lurking out there in this NY Times news article, "The Safety Gap." The article is extremely well written and is full of anecdotes, statistics, and critical analysis that will make you think twice about the food and drugs that all of us are personally using. Here's what made me cringe . . .

1. It worries me that contributors to the story wanted to remain anonymous. It seems to me that perhaps the problem is much bigger than folks are willing to admit.
2. I'm guessing that the contaminated heparin from China incident is probably just the tip of a massive iceberg.
3. No surprise, the FDA is underfunded, understaffed, and ill-equipped to deal with the pent-up demand for foreign plant inspections.
4. It appears there is a danger that foreign plants are less committed to quality standards, and in some cases demonstrate a lack of ethical behavior.
5. I could go on, but it's much The Safety Gapfor you to read the news article.

Let the buyers beware (that means us as consumers, and companies partnering with foreign plants). 

Previous Posts: 

The Health, Drug, Prescription, and GMP Supersite: FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants 

Return Home: http://drughealth.blogspot.com/ 

FDA Creates New Web Page of Drug Safety Information

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs, "Postmarket Drug Safety Information for Patients and Providers." On this page you'll find many resources organized in the following categories . .

• Drug Labeling
• Risk Evaluation and Mitigation Strategies (REMS)
• Studies and Clinical Trials of Approved Products Required by FDA or Agreed to by the Application Holder
• Registries and Clinical Trials
• Memorandum of Agreement Between the Office of New Drugs and the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
• Latest Safety Information
• Reporting Problems to the FDA
• Warnings and Recalls
• Regulations and Guidance Documents
• Information about FDA's Drug Safety Oversight Board (DSB)
• Using Medicines Safely
• Consumer Articles on Drug Safety
• General Health Information
• FDA's Response to the Institute of Medicine's 2006 Report

Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/