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Generic Abuse-Deterrent Opioids: Comparison To Brand Will Not Require Use Of Control

 
• By Brenda Sandburg

FDA final guidance recommends comparative pharmacodynamic studies for nasal and oral routes of abuse, simplifies statistical approach to show deterrence of generic is same as brand.

Hydrocodone prescription bottle. Hydrocodone is a generic medication name and label was created by photographer.

FDA has heeded the advice of stakeholders and eliminated its recommendation that manufacturers of generic abuse-deterrent opioids compare the brand to a control product for certain studies.

The agency's draft guidance to assist industry in developing generic versions of approved abuse-deterrent formulations (ADFs) advised that for certain comparative studies, such as extractability studies, discriminatory conditions should be...

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US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

More from Agency Leadership

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
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Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
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The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.