The FDA has issued a warning letter to a website that has been selling the antiparasitic drug ivermectin as a treatment for Covid-19. The correspondence directs the company to stop selling its products and correct any misleading language in its marketing material.
The FDA issued a warning letter about nicotine gummies—the first ever notification sent for such a product. The agency’s concern is that the flavored gummies resemble candy and pose a toxicity risk to children.
Over the past several years, FDA has been more aggressive and active in performing medical device company inspections. This has lead to a far greater number of companies receiving form 483 warning letters and citations. 483’s are a good way for your medical device company to flush $400,000 down the drain. Has it been a […]
The FDA just sent Pathway Genomics a warning letter for its new liquid biopsy test, calling it "a high risk test that has not received adequate clinical validation and may harm the public health."
This is a story I recently heard from a medical device startup who lost over $400,000 dealing with the aftermath of an FDA compliance inspection.
Here are a few long reads beyond just where the FDA warning letter told genetic testing startup 23andMe to put it. Check out these smart takes while you’re stuck in line at the grocery for an hour. (How could you forget yams?!) If you think your family dinner arguments are heated, you won’t want to miss […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
A person in Cambridge, Mass., filed a petition on Nov. 25 with the White House to “overrule” the FDA’s warning letter to 23andMe, which demands the company halt sales of its genetic testing spit kits. Registered under healthcare, space and science policy and regulatory reform, the petition reads: WE PETITION THE OBAMA ADMINISTRATION TO: overrule […]
Star startup 23andMe got slammed with an FDA warning letter Nov. 22. The letter says the healthcare startup’s genetic testing spit kits are being marketed without clearance or approval. It goes so far as to say the diagnostics applications, including “carrier status,” is a medical device usage, and therefore requires premarket approval or de novo […]
After a difficult premarket approval process and tenuous relationship with the FDA, Atlanta’s CardioMEMS received a mixed message from an FDA advisory panel on its CHAMPION HF Pressure Measurement System, an implantable sensor monitor to help guide treatment in patients with congestive heart failure. The panel voted unanimously that the device was safe, the majority […]
Greenleaf Health LLC has issued a new report titled “FDA Medical Device Enforcement Report,” and some of the numbers in there are surprising to say the least. Especially given the context of constant complaints from the medical device industry regarding its regulatory burden. The Greenleaf Health executive summary paints a picture of the broader agency […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Analyst Bob Hopkins of Bank of America was mystified and sounded a bit worried on the St. Jude Medical (NYSE:STJ) morning conference call to discuss the company’s third-quarter earnings Wednesday. St. Jude CEO Dan Starks had just done the unthinkable. He had warned investors that he was expecting a warning letter from the U.S. Food […]
A Swiss plasma product manufacturer’s U.S. division, Octapharma USA, has received a warning letter from the U.S. Food and Drug Administration over what was described as “false and misleading” advertisements in a journal and product catalog. The U.S. regulator said in the April 10 letter that an ad for its octagam immune globulin intravenous 5% […]
