Derrick Gingery on Muck Rack

Derrick Gingery

Verified
Maryland
As seen in: The Pink Sheet, BioXconomy, Citeline, Generics Bulletin, HBW Insight, Medtech Insight, Scrip, BioProcess International Magazine, Med Device Online, Friends of Cancer Research, Pharmaceutical Online and
An Indiana Hoosiers fan, news junkie, health care journalist @PharmaPinkSheet, @IUBloomington alum, and soon a novelist. Opinions are my own.
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Articles

US FDA Begins Search For Cell, Gene Therapy Office Director

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By Derrick Gingery Verified
| The Pink Sheet Verified
CBER's Office of Therapeutic Products has been without a permanent director since June 2025. Applications for OTP director are due July 21. (Shutterstock) The US Food and Drug Administration has decided to find a new permanent director for its office overseeing cell and gene therapies after more than a year of temporary management. The agency issued the job notice for the Center for Biologics Evaluation and Research’s Office of... FDALeadershipUnited StatesGene Therapy
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Biosimilar Development Fees Dropped As US FDA And Industry Concluded BsUFA IV Negotiations

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By Derrick Gingery Verified
| The Pink Sheet Verified
BsUFA IV also won’t include different fees for applications with clinical data, a sign of the maturing regulatory processes and expanding market prospects for biosimilars. Significant user fee changes are coming for biosimilar sponsors beginning in fiscal year 2028. (Shutterstock) Key Takeaways The FDA and industry decided to eliminate the biosimilar product development fee as part of the upcoming BsUFA reauthorization.
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US FDA Saw PDUFA FY 2025 Payroll Costs Rise Despite Layoffs

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By Derrick Gingery Verified
| The Pink Sheet Verified
The increase likely occurred in part because of required severance payments for laid off workers, but a sharp decline is expected in FY 2026, followed by another jump in FY 2027. The FDA saw payroll costs increase in FY 2025 despite losing hundreds of people. (Shutterstock) Key Takeaways PDUFA and BsUFA payroll costs increased in FY 2025, despite the massive layoffs and other voluntary departures imposed by the Trump Administration.
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