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 AdComm Asks Many Questions About COVID Vaccine For Ages 5-11, But Gets Few Answers
Often data was not available from FDA, CDC or the sponsor to answer subgroup, safety and other questions that could have influenced the outcome of the advisory committee meeting.
Full US FDA Independent Review Of Janssen Booster Data May Not Continue Post-EUA
The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.
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New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.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.