Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition - FDA.gov

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According to the FDA:

"The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose. The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.

Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established ... "

Source: 

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication - FDA.gov

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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As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety, and effectiveness | FDA Voice

As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety, and effectiveness | FDA Voice:

"Materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts. Scientists can use these features to enhance the properties or the quality of a drug. But because such properties can affect the quality, safety, or effectiveness of a drug, FDA is studying these issues related the use of this powerful new technology in medical products."

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SharedClarity Evaluates Implanted Medical Device Effectiveness

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Three Large Health Systems and UnitedHealthcare Launch SharedClarity, a New Venture to Study Long-Term Effectiveness of Medical Devices | Business Wire: 

"Three large U.S. health systems and one of the nation’s largest health benefits companies today launched a new venture to conduct independent studies on the long-term effectiveness of medical devices that are implanted into patients for everything from heart problems to bad knees and hips.   

“SharedClarity was formed to help our members deliver high-quality care to their patients”

The new venture, called SharedClarity, includes Dallas-based Baylor Health Care System, San Francisco-based Dignity Health, and Illinois-based Advocate Health Care, along with UnitedHealthcare."

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FDA's Stance On Online Pharmacies May Go Too Far, Study Says : Shots - Health Blog : NPR

FDA's Stance On Online Pharmacies May Go Too Far, Study Says : Shots - Health Blog : NPR:

"The Food and Drug Administration has warned people about the many dangers of buying medications from foreign pharmacies over the Internet. While some sites might offer high-quality medicines, there are plenty that sell bogus and potentially dangerous products.

But a recent economic analysis suggests that while there's good reason for the safety warnings, the FDA's stance on the matter might go too far. Many Americans don't fill their prescriptions because they can't afford to, the study says, and some legitimate foreign pharmacies may offer medicines at prices lower than those of verified U.S. suppliers."

. . . "In light of this," the researchers asked, "we wonder whether a blanket warning against foreign websites has limited price competition between U.S. and foreign websites, and whether a more open and educational policy could make better use of the existing verification services for consumer savings in authentic drugs."

'via Blog this'

Read about the FDA's stance on Buying Medicines Over The Internet

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FDA Medical Device Controversies - Approvals and Clearance

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I thoroughly enjoyed reading this Health News Digest article, Is That Medical Device Safe And Effective? Who Knows? It's a great overview of:

• medical device classification
• premarket approval (PMA)
• premarket notification (510(k))
• substantially equivalent
• anecdotes that highlight controversies in the items above. This is the best part of the article.

For me, I get the sense that it's generally about business, and that some unethical companies might be putting our collective safety at risk.

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FDA Collaborates On Nanotech Initiative

The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. I'm glad to see this. Until nanotechnologies are better and more deeply understood, it makes sense to me that the best minds thinking about nanotech are collaborating. More FDA Information: FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative - Overarching goal: developing an efficient pathway for safe and effective nanoengineered medical products 

Related Posts: Should The FDA Oversee Nanotechnology Dietary Supplements? Go For Gold - I Mean Nanoparticles And Drugs FDA - FAQs About Combination Products 

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Testing Approved Drugs In The Real World With Real People

Updated November 25, 2022

The original link broke.

You can still read about the same topic here:

New Arena for Testing of Drugs: Real World - TuscaloosaNews.com

---  the original post follows below  ---

In the drug development process, drugs are clinically tested in very select patient populations. This means that once a drug gets approved, the drug is often given to quite a different kind of patient population, and the results of drug treatment could be different. For the big picture, read this compelling Star News Online article, "New Arena for Testing of Drugs: Real World." I find the story so compelling for the following reasons . . .

1. Patients, health care professionals, and the pharmaceutical industry bring their own unique health and business issues or needs to the table
2. It's ultimately about the patient, and there's a need to know whether approved drugs help or harm in the real world

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