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)
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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 number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.
By: Derrick Gingery
Chief Medical Officer Hilary Marston says a black box model could be a problem for reviewers, after CDER and CBER officials said unexplainable AI models could be acceptable but transparency is important.
By: Derrick Gingery, Cathy Kelly, Sarah Karlin-Smith
Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations, legal wrangling related to compounding GLP-1 drugs for obesity and diabetes, and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable.
US FDA commissioner says the agency plans to look for clinical trial fraud in applications using artificial intelligence, in part to find problems sooner.
By: Derrick Gingery
Generics of the schizophrenia treatment Latuda generated more than $4bn in savings a year after their 2022 approval, according to an FDA study.
Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.
By: Sarah Karlin-Smith, Derrick Gingery
Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make to the FDA, as well as worries about political interference in decision-making, and policy and staffing changes.
By: Sarah Karlin-Smith, Michael McCaughan, Derrick Gingery
Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump's potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS, and FDA Commissioner Robert Califf's request that industry help preserve the agency status quo.
By: Derrick Gingery
When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.
By: Sarah Karlin-Smith, Derrick Gingery
Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization, as well as the changes Dr. Mehmet Oz, President-elect Donald Trump's controversial selection to run the US Centers for Medicare and Medicaid Services, could impose if confirmed.
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