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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

Remdesivir’s Path To Orphan Designation Could Be Exploited By Others, Experts Warn

Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.

Rare Diseases Drug Review

Vaccine Hesitancy May Drive Distribution Priorities For Early COVID-19 Supply

ACIP defers vote on who should be inoculated first until it has data on a specific product, but vaccine acceptance among different groups could be weighed as factor in setting distribution priorities, committee members suggest.

Coronavirus COVID-19 Vaccines

Could A COVID-19 Vaccine Gain EUA Without Sponsor Cooperation?

The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.

Coronavirus COVID-19 Vaccines

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
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