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
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.
The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.
Briefing documents for the upcoming advisory committee tout potential ‘indirect’ benefits and argue that lower dose should address myocarditis concerns.
New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.
Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.
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.