Derrick Gingery
Senior Writer
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
Harmonizing COVID Vaccine Schedule Good Idea, But US FDA Should Remain Flexible, Advisors Say
Vaccines and Related Biological Products Advisory Committee also said that more data is needed to determine the groups that potentially could receive more than one periodic vaccine booster.
US FDA Still Not Scheduling In-Person Meetings Despite Sponsor Requests
Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.
‘We Don’t Hold Regulatory Actions For Press’ – Inside FDA’s Communications Difficulties And Misinformation Fights
Internal US FDA emails illustrate the difficulties coordinating regulatory decisions and communications about them as the agency considers growing its allies in the war against misinformation.
Could The Nightly Weather Report Help Rebuild Trust In The US FDA?
FDA officials joked about the possibility of having a regular TV segment to explain its activities, but Commissioner Califf believes the networks would not want it.
Rare Disease Expertise On FDA Advisory Committees Gains Capitol Hill Attention
With Congress watching whether enough experts are on advisory committees for orphan drugs, the US FDA may be pressured into changes.
How US FDA Explained The Difference Between Approved And EUA Pfizer/BioNTech COVID-19 Vaccine
When Comirnaty was approved in 2021, the product in the vials was identical, but the agency still had to state that legally they were different without confusing people.