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Derrick Gingery

Senior Writer

Washington, DC
Senior writer Derrick Gingery has been reporting on regulatory issues for "The Pink Sheet" and "The Pink Sheet" Daily since 2010. Among his favorite topics are FDA's user fee programs, along with generic drug and biosimilar policy, but he also handles drug approval issues and general FDA news.

An award-winning journalist, Derrick has written extensively about user fee negotiations, the FDA budget, FDA travel restrictions and drug advertising compliance. He also was part of the Pink Sheet team covering FDA's first biosimilar advisory committee meetings.

When he's not following FDA, Derrick is keeping close tabs on Indiana Hoosiers basketball.

Latest From Derrick Gingery

Pfizer COVID-19 Vaccine Trial Diversity Slips As Enrollment Rises, Unlike Moderna

Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.

Coronavirus COVID-19 Clinical Trials

Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents

Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.

Coronavirus COVID-19 Vaccines

Preventing Missing Data Among Concerns In US FDA’s Guidance On COVID-19 Symptom Assessment

Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.

Coronavirus COVID-19 Clinical Trials

User Fee Renewal Negotiations Beginning This Week

Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.

User Fees FDA

After First COVID-19 Vaccine Approval, How Will Other Trials Maintain Placebo Control?

US FDA officials fear comparator arms would be unwieldy for ongoing trials as they consider alternative methods to measure efficacy if placebo controls can't be maintained for the studies of other candidate vaccines once a product is on the market.

Coronavirus COVID-19 Vaccines

Pink Sheet Podcast: COVID-19 Vaccine Trial Stopped, Sponsor Filing Pledge, Rare Voucher Extended

Pink Sheet reporters and editor discuss the ramifications of the AstraZeneca vaccine trial hold and vaccine sponsors pledging to wait until the completion of Phase III before submitting applications, as well as efforts to extend the rare pediatric disease priority review voucher program.

Coronavirus COVID-19 Vaccines
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