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.
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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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The bill permanently schedules fentanyl analogues as Schedule I drugs under the Controlled Substances Act.
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The Jha brothers admitted selling counterfeit Keytruda and other prescription drugs to undercover agents.
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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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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.
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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.
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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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Operation RapTor led to 270 arrests and the seizure of more than $200 million in currency and digital assets.
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Articles in Endpoints News and the Houston Chronicle raise questions about the regulatory process for 503B compounding facilities.
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