News
FDA announces changes to section 804 importation program proposals
A July 1, 2025 post clarifies that applicants can use “a static baseline approach for the cost-savings analysis” instead of trying to account for changes in unpredictable markets.
[...]June 30, 2025: Operation Pangea XVII nets $65 million in unapproved and counterfeit medicines
The operation launched 1,728 investigations in 91 countries and shut down 13,000 criminal-linked websites, social media pages, channels, and bots used to market and sell illegal or counterfeit medicines.
[...]PSM writes to support changes to FDA’s Medwatch reporting system
On June 26, PSM commented in support proposed revisions to forms FDA 3500 and FDA 3500B, which are used to report adverse events from prescription and over-the-counter medicines.
[...]June 23, 2025: New botulism outbreaks tied to suspect Botox injections
More than 40 cases of botulism linked to Botox injections have been reported in the U.S. and U.K. over the last two months.
[...]June 16, 2025: Congress passes the HALT Fentanyl Act
The bill permanently schedules fentanyl analogues as Schedule I drugs under the Controlled Substances Act.
[...]June 9, 2025: Two Indian men pleaded guilty to smuggling counterfeit cancer medicine into the U.S.
The Jha brothers admitted selling counterfeit Keytruda and other prescription drugs to undercover agents.
[...]DRAFT: Best practices for drug safety for online pharmacy to pharmacy to pharmacy marketplaces
PSM is soliciting feedback on draft best practices until June 20th. Please review the guidelines and send your thoughts to editors@safemedicines.org.
[...]June 2, 2025: FDA continues to protect Americans from unapproved and contaminated medicine
The FDA warned companies over the sale of an unapproved medical device and contaminated eye medicines, and disbarred a Texan who sold illegally imported pharmaceuticals.
[...]FDA Alert: Nationwide recall of Unavy and Umovy supplements for undeclared drug ingredients
The FDA has announced a voluntary nationwide recall of two dietary supplements sold exclusively online by www.umary-usa.com. Lab testing revealed that Unavy Ácido HIALURÓNICO and Umovy Ácido HIALURÓNICO contain undeclared active pharmaceutical ingredients: diclofenac, dexamethasone, and omeprazole.
[...]The End of GLP-1 Compounding
Federally-registered compounding facilities stopped making tirzepatide on May 22. This transition is significant for patients, and we at PSM think there are four things you should be watching for.
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