Derrick Gingery
Senior Writer
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 Push For COVID Vaccine EUA In Ages 5-11 Includes School, Mental Health Arguments
Briefing documents for the upcoming advisory committee tout potential ‘indirect’ benefits and argue that lower dose should address myocarditis concerns.
Real-World Evidence: ‘Labor-Intensive’ Data Standardization May Be Required By US FDA
New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.
Potential For Califf’s Second Term As US FDA Commissioner Surprises, Excites Stakeholders
Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.
Janssen Gets US FDA Panel Nod For Additional COVID Vaccine Shot – But Is It A ‘Booster’?
Advisory committee members say clinical data proves the second shot should be considered part of the primary series, while Janssen wants it called a single-shot vaccine with a booster.
Potential For Califf’s Second US FDA Commissioner Term Surprises, Excites Stakeholders
Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.
Janssen Booster Evidence Draws Questions From US FDA, But Also A Nod Towards Benefits
Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.