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Prescription Drug Affordability Board Activity, May 2025
Prescription Drug Affordability Board Activity, May 2025 Activities Summary Colorado: Colorado’s PDAB met on May 23 to approve the Data Submission Guide and begin rulemaking around an upper payment limit for Enbrel. Oregon: At its May 21 meeting Oregon’s PDAB discussed the timeline and process for affordability reviews and approved the generic drug report. One…
[...]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.
[...]May 27, 2025: Global effort to disrupt darknet marketplaces yields 4,400 pounds of illicit drugs
Operation RapTor led to 270 arrests and the seizure of more than $200 million in currency and digital assets.
[...]May 19, 2025: Investigations raise questions about product safety at a Texas compounding company
Exposes in the Houston Chronicle and Endpoints News examined Empower Pharmacy’s safety record. A grand jury indicted a Chinese company and three of its employees for pill press and counterfeit die mold sales.
[...]Case overview, USA v Capsulcn International Co Ltd et al
In May 2025, the U.S. District Court in the Western District of Texas unsealed an indictment against a CapsulCN International and three Chinese nationals for their alleged role in the illegal importation of pill-making equipment.
[...]Indictment, USA v CapsulCN International Co Ltd et al
April 23, 2025
[...]May 12, 2025: FDA will expand unannounced foreign facility inspections, it says
The FDA wants to ensure that domestic and foreign companies receive the same level of regulatory oversight.
Catch up on research PSM released about medicines imported from unregistered sources.
[...]Prescription Drug Freight Fraud Report, May 2025
What if your blood thinners were made in an unverified location in Colombia? In March 2025, dozens of pharmaceutical shipments entered the U.S. that were manufactured in places no one would expect.
[...]Pharmaceutical Border Security
Pharmaceutical border security Every day, inspectors from Customs and Border Protection, the Food and Drug Administration, and the Drug Enforcement Administration intercept scary medical products entering the U.S. This work is incredibly important to protect the safety of American patients and it’s difficult because criminals never stop innovating. PSM supports the work of border inspectors…
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