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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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.
Numerous staff positions at the US FDA could be the target of incoming administration efforts to remake the federal bureaucracy.
By: Derrick Gingery
An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.
By: Cathy Kelly, Sarah Karlin-Smith, Derrick Gingery
Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccines under the Trump Administration, the DOGE commission's search for spending cuts and its impact on the FDA, as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program's costs.
By: Derrick Gingery
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.
By: Sarah Karlin-Smith, Derrick Gingery
President-elect Trump is backing a government funding bill that cuts pharma priorities, but it remains unclear whether the plan will garner enough votes to prevent a government shutdown.
By: Derrick Gingery
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
Amid complaints about the challenges of following gene therapy patients for up to 15 years, OTP Director Nicole Verdun said the FDA is considering how to conduct long-term postmarket studies more efficiently.
By: Derrick Gingery, Jan By
The chair of the Senate Health, Education, Labor and Pensions Committee questioned whether Kennedy could reject anti-vaccine views in the face of data affirming their safety and efficacy.
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