Posts by PSM Author
Director of Health and Science Policy at Citizens Against Government Waste Calls Drug Importation Dangerous
Instead of wasting time and money on dangerous and faulty importation proposals, Congress should encourage the FDA to speed up the drug approval process and reduce the cost of program and application fees for future drug development. In 2022, the application fee for a human drug application will cost $1.6 million for drugs that don’t require clinical data and $3.1 million for medicines that do need clinical data.
[...]FDA Alert: Class 1 Recall of Some Mesa Biotech COVID Tests Due to Risk of False Positives/Contamination
This is a reprint of an FDA Alert. Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Accula…
[...]FDA Alert: Class 1 Recall on Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test
This is a reprint of an FDA Alert. Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication May 10, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). This test is not authorized, cleared, or approved…
[...]FDA Alert: Herbal Arthritis Treatments Contain Dangerous Prescription Drugs
FDA has received adverse event reports, including of liver toxicity and death, associated with the use of Artri King products, since the agency issued its first warning about an Artri Ajo King product on January 5, 2022.
[...]FDA Alert: Class 1 Recall of Unauthorized Covid-19 Tests
This is a reprint of an FDA Alert. SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious…
[...]FDA Issues Warning About Unauthorized Covid-19 At-Home Tests
The U.S. Food and Drug Administration (FDA) is warning people not to use the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test. The test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. This unauthorized test may be packaged in a white and magenta box.
[...]March 2, 2022 Video: Stop Notorious Websites
Learn how this year’s Notorious Markets Report illustrates need for the DRUGS Act.
[...]Dietary Supplement Sold on Amazon Recalled for Containing Prescription Drug Ingredients
Esupplementsales, LLC was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Hard Dawn Rise and Shine Capsules renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
[...]Video: Fake Cough Syrup Ring in Texas
Is there money in counterfeit cough syrup? There really is—but you can never tell what’s in fake medicine and sometimes it will kill you. Watch this week’s video to learn about a recently busted cough syrup ring in Texas.
[...]Texas eBay Seller Recalls Diet Supplements Containing Banned Sibutramine
Am eBay seller is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level because FDA analysis has found the product to contain undeclared sibutramine, an appetite suppressant that was withdrawn from the market because of safety issues.
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