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Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says

 
• By Cathy Dombrowski

Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.

Penalties for misbranding drugs need to be tougher in order to combat counterfeiting, FDA Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg told the House Energy and Commerce Subcommittee on Oversight and Investigations Feb. 27.

If counterfeiting is charged as an intellectual property offense (trafficking in counterfeit goods), the maximum prison term is 20 years...

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
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US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

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