Ingestible fluoride products used to prevent dental caries have a long and twisted regulatory history relative to their permitted marketing status. After searching the web for an explanation, I found an interesting article (here) published by the Fluoride Action Network. I provide this article as it gives a reasonable historical account of the avenues along which the […]
Having been around the block more than a few times, the position of the FDA regarding pricing is clear. The Agency is not supposed to take pricing considerations into drug approval or enforcement decisions. However, there is controversy swirling around the FDA’s recent decision on the drug shortage for GPL-1 obesity medications and the practice […]
The Food and Drug Administration is advising consumers not to purchase or use the following products that are marketed as dietary supplements as they contain undeclared drug products that could be harmful: VITAFER-L Gold 10 ml may be harmful due to hidden drug ingredient tadalafil VITAFER-L Gold 20 ml may be harmful due to hidden drug ingredient […]
Well, there is bad, then there is worse! In this case, the FDA warns us about a product that is being marketed as all natural and promoted as a dietary supplement for joint and muscle pain. The product, called Trinity Gold, actually contains three undeclared drug ingredients, acetaminophen, diclofenac, and phenylbutazone (which was removed from […]
U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight. Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]
Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]
We have written a lot about fraudulent drugs over the years. Some examples of these include counterfeit drugs, dietary ingredients that are unsafe, dietary drugs that contain undeclared prescription drugs in them, and the list goes on and on. In his presentation titled “Fraudulent Drugs: You’re Taking What?” (here), Brad Pace, Associate Director, Office of […]
In a press release issued yesterday (here), the FDA warned six companies about topical lidocaine products that can cause serious health effects and are also unapproved new drugs. The products are recommended for use after certain dermatological procedures “such as microdermabrasion, laser hair removal, tattooing and piercing.” These products are being marketed at concentrations above […]
Yesterday, the FDA advised consumers not to use QUICK Rheumatism Capsule, Tiger Wang Biaod (here) or SNAKE BONES Anti-Rheumatic Capsules (here). The FDA confirmed by its laboratory analysis that both products contain piroxicam, a prescription drug ingredient for treating pain and arthritis-related symptoms. Serious adverse events can occur with taking any of these unapproved drugs […]
Since the implementation of the CARES Act reporting requirement, the question continues to be asked: Is it really a requirement? The answer is yes, and now it is no longer recommended, but is stated as “should” in the newly published Final version of the Guidance for Industry (GFI) “Reporting Amount of Listed Drugs and Biological […]
