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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The agency's draft guidance to assist industry in developing generic versions of approved abuse-deterrent formulations (ADFs) advised that for certain...

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Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
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The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.

First Cohort Shows Many Routes To US FDA’s Commissioner’s National Priority Voucher

 
• By Sarah Karlin-Smith

Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds of candidates.

US FDA Drug, Biologics Centers Lost Nearly 1,000 Employees In FY 2025 Fourth Quarter

 
• By Derrick Gingery

The hiring and departure data provide more evidence of the extent of the Trump Administration’s efforts to shrink the FDA workforce through cuts and voluntary departures.

Pink Sheet Podcast: US FDA Involved In Drug Pricing Deal, DOJ’s Off-Label Promotion Policy

 
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Pink Sheet Podcast: US FDA Involved In Drug Pricing Deal, DOJ’s Off-Label Promotion Policy

 
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With US FDA Adcomm Meetings Disappearing, Sponsors Seek Other Outlets For Patient Voice

 
• By Derrick Gingery

Formal meetings like application orientation sessions or patient listening sessions are becoming increasingly important as the FDA schedules fewer advisory committee meetings for applications, experts said.

US FDA Could Use Shutdown To Improve Amid Growing Foreign Competition

 
• By Alaric DeArment

Panelists at the BioFuture conference discussed the potential opportunities the government shutdown creates for the FDA to improve flexibility and efficiency.