News
July 21, 2025: Inspection policy for all FDA-regulated products changed at ports of entry
A policy change announced by U.S. Customs and Border Protection means that all FDA-regulated products are now subject to inspection at ports of entry.
[...]What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?
503B outsourcing facilities make our drug supply more resilient, but 81% of 503Bs newly registered since June 2021 have never been inspected by FDA staff. Learn why we recommend changes to this important program.
[...]Pill press update: January through June 2025
Pill presses and molds are used to make fake pills with deadly consequences thousands of people every year. The number of Americans that take fake pills annually without a fatal event is even higher. Read our January through June 2025 report covering pill press seizures, policy developments, and legislation.
[...]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.
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