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 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 - Preparation Tips For Meetings With The FDA

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If you have upcoming meetings with the FDA, or are looking for ways to be more effective during the meeting, then this slide deck is a must read, Strategies to Prepare for Meetings with the FDA by Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA (circa 2006). In summary, she highlights these 3 things:

• Meetings Are a Critical Component of the Way We (Industry and FDA) Do Business
• Extensive Framework Around Meeting Process and Procedures Enhance Predictability
• Efficient Use of Meetings Facilitates Our Shared Public Health Goal

Related Posts: FDA Guidance - FDA and Sponsor-Applicant Meetings

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The Medical Device Safety Act of 2009

It's a firestorm! The FDA announced that makers of certain older and risky medical devices will have to prove that their products are safe and effective according to the New York Times. This is a very hot issue. Related to this, I just read an editorial published by NEJM (the New England Journal of Medicine): The Medical Device Safety Act of 2009. Who's side are you on? The patient? Industry? Litigation attorneys? Others? 

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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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Gardasil, the HPV Vaccine, Is Safe, Says FDA and CDC

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Updated November 11, 2020.

It's good news to hear that an approved vaccine, Gardasil (the vaccine against HPV, Human Papilloma Virus) is still safe to use, as reported in this Reuters news article, "US FDA, CDC back Merck's Gardasil shot as safe." The Reuters article covers the highlights, and is more readable than the more detailed information made available by the FDA, "Information from CDC and FDA on the Safety of Gardasil Vaccine." 

Bottomline, Gardasil continues to be safe and effective to use. If this applies to you or your children, then consider this and get vaccinated, this vaccine prevents infection with the types of HPV that cause most cases of cervical cancer and genital warts. 

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