Derrick Gingery is a journalist with a focus on national issues in the United States. His work has been featured in publications such as Friends of Cancer Research and Informa. Derrick covers topics related to the US FDA, including regulations, guidance, and scientific disagreements.
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United States (National)
Derrick Gingery's coverage primarily focuses on the healthcare and pharmaceutical industry in the United States, with a strong emphasis on government announcements, legal policy regulation, and press releases. He appears to be particularly interested in developments related to the US FDA, regulations impacting drug development, and medical research.
Given his focus on regulatory changes within the pharmaceutical industry at a national level, Derrick would likely respond well to pitches from experts familiar with US FDA procedures and policies or individuals directly impacted by these regulatory changes. Consider offering insights into how specific regulations or government announcements may affect drug development processes or medical research within the United States.
Since he covers topics related to pharmaceuticals and healthcare regulations extensively without an international focus mentioned explicitly, it is best to tailor pitches that are relevant specifically to U.S. regulatory matters rather than global issues.
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The agency used a 10-year average with updated figures to calculate the FY 2025 PDUFA application fee and limit the impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket.
By: Sue Sutter, Derrick Gingery
The US FDA’s Genetic Metabolic Diseases Advisory Committee will comprise three regular voting members and 13 temporary members, including some adcomm veterans, when it reviews Zevra Denmark’s arimoclomol for Niemann-Pick disease type C.
A lack of process documentation was part of the reason the FDA forgot to account for fee refunds in its estimates of incoming applications for two fiscal years, a mistake that likely cost the agency millions in revenue.
By: Derrick Gingery, Sarah Karlin-Smith, Sue Sutter
Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams’ views on how the FDA can better ensure clinical trial diversity, questions about approving a new drug that would be used with a standard of care regimen that is off-label, and the agency beginning to schedule fully in-person advisory committee meetings.
By: Derrick Gingery
Amid a push for new incentives, the US FDA’s Kerry Jo Lee, associate director for rare diseases in the Center for Drug Evaluation and Research’s Office of New Drugs, said in an interview with the Pink Sheet that the tools ultra-rare sponsors need already are available.
By: Derrick Gingery, Sarah Karlin-Smith, Cathy Kelly
Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.
By: Derrick Gingery
Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.
Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion, as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned.
Rare disease activities within the biologics center will gain more prominence with a senior official overseeing them.
By: Derrick Gingery
FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.
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