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Opioid Packaging: Is Non-Inferiority Enough For A New Claim?

 
• By Derrick Gingery

Industry exec suggests new packages need be merely no worse than the classic amber vial to gain a claim, but US FDA says packaging intended to fight abuse should be better.

FDA entrance sign 2016

The US FDA does not appear interested in setting a low bar for opioid packaging claims, possibly creating some tension in its nascent efforts to work with industry to redesign the opioid dispensing paradigm.

The question of how to encourage opioid packaging that could prevent overprescribing and potentially reduce addiction places industry and FDA in an awkward position

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US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
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US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
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US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
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Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.