News
July 14, 2025: Counterfeit Keytruda peddlers sentenced in federal court
Avanish Kumar Jha and Rajnish Kumar Jha got 30-month sentences for selling counterfeit medicines—including vials of fake Keytruda—to U.S. buyers.
[...]An FDA inspection revealed significant problems at Empower’s new outsourcing facility
After a November 2024 inspection, the FDA issued a Form 483 to Empower Clinic Services highlighting violations related to compounded drug manufacturing practices at its East Windsor, New Jersey facility.
[...]July 7, 2025: Google to block promotion of pill presses on ads and shopping platforms
The change will affect the Google Ads and Google Shopping platforms starting in September 2025.
[...]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.
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