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
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.
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.
The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.
Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.
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.
Investigators should plan to find the vital status of discontinued patients, guidances states. Participants need frequent reminders to complete PRO instruments, agency recommends.