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 week ago |
insights.citeline.com | Derrick Gingery
FDA Reverses Course, Allows Some Telework For ReviewersThe new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day. (Evgeny Atamenenko/Shutterstock)
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2 weeks ago |
insights.citeline.com | Derrick Gingery
US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related ProblemsThe new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day. FDA reviewers now can telework two days per week. (Shutterstock)
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2 weeks ago |
insights.citeline.com | Derrick Gingery
US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day. FDA reviewers now can telework two days per week. (Shutterstock)
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2 weeks ago |
insights.citeline.com | Derrick Gingery
Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal PenaltyStaffing Cuts At FDA Could Threaten Ability To Collect Biosimilar User FeesMassive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
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2 weeks ago |
insights.citeline.com | Derrick Gingery
Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal PenaltyMassive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff. Staffing cuts at the FDA could threaten its ability to collect biosimilar user fees. (Shutterstock)
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RT @PharmaPinkSheet: Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say https://t.co/OKdHYRCfb6 #PinkSheet…
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Unfortunately, the tariff threat is not over ... @PharmaPinkSheet @PharmaScrip ... Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster https://t.co/vlBqddqPXf
