Derrick Gingery

Derrick Gingery

Senior Writer

Washington, DC

Derrick focuses on the US FDA user fee programs, regulations and policy for new and generic drugs, biologics and biosimilars, advisory committee and other agency activities, as well as federal legislation and budget matters on Capitol Hill. He also hosts Pink Sheet's Pharma Regulatory Podcast. An award-winning journalist, Derrick has been a reporter for several community newspapers and a business journal. When not following FDA, Derrick is keeping close tabs on Indiana University basketball.

Latest from Derrick Gingery

US FDA Floats Communications Upgrade For ANDAs With Missed Goals

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.

US FDA Floats Communications Upgrade For ANDAs With Missed Goals

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.

Latuda, Other Generics Cleared In 2022 Helped Generate Nearly $19bn In Savings, US FDA Says

Generics of the schizophrenia treatment Latuda generated more than $4bn in savings a year after their 2022 approval, according to an FDA study.

Latuda, Other Generics Cleared In 2022 Helped Generate Nearly $19bn In Savings, US FDA Says

Generics of the schizophrenia treatment Latuda generated more than $4bn in savings a year after their 2022 approval, according to an FDA study.

‘Be Honest’: Califf Warns As AI Will Help Fight Clinical Trial Fraud

US FDA commissioner says the agency plans to look for clinical trial fraud in applications using artificial intelligence, in part to find problems sooner.

Pink Sheet Podcast: SubQ Drugs And Price Negotiations, GLP-1s In Court, US FDA Approach To Black Box AI

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.