
Derrick Gingery
Senior Writer at The Pink Sheet
An Indiana Hoosiers fan, news junkie, health care journalist @PharmaPinkSheet, @IUBloomington alum, and soon a novelist. Opinions are my own.
Articles
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1 day ago |
insights.citeline.com | Derrick Gingery
PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A ThemeOngoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year. Program fees could be a way to eliminate perceived conflicts of interest with the user fee program. (Shutterstock)
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4 days ago |
insights.citeline.com | Derrick Gingery
US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director. Commissioner Martin Makary continues to remake the FDA's senior leadership team. (Shutterstock)
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1 week ago |
insights.citeline.com | Derrick Gingery
Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy OfficeKumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted. CBER named an acting director of OTP two days after ousting director Nicole Verdun. (Shutterstock)
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2 weeks ago |
insights.citeline.com | Derrick Gingery
US FDA Teases Disclosure Program, But Industry Has Seen This Before Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress. Will consolidation of the FDA's FOIA/disclosure staff limit the resources available to redact documents for public release? (Shutterstock)
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2 weeks ago |
insights.citeline.com | Derrick Gingery |Francesca Bruce |Cathy Kelly |M. Nielsen Hobbs
Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug PricingPink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry. Would EU nations accept higher drug prices so the US could pay less? • Source: Citeline/Shutterstock
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ICYMI on Friday ... The latest @PharmaPinkSheet podcast with me, @PinkSheetSutter, @SarahKarlin, and @PinkSheetHobbs: Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts https://t.co/n9bsYjV5JP

Can you issue a final diversity action plan guidance when the draft was pulled because of the DEI crackdown? @PharmaPinkSheet's @PinkSheetSutter considers ... Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms https://t.co/2oErD9bi0Z

Considering the options payment cap advisory boards could have as they grow more popular ... @PharmaPinkSheet: Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says https://t.co/DAaqufsUS6