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
CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge.
With some studies about to finish and others on clinical hold, the coronavirus vaccine field approaches an inflection point as the US FDA prepares for its first advisory committee on the topic. Our charts and graphics offer a quick look at what stands where.
Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.
US FDA has the unenviable task of picking the most important adverse events to track once coronavirus vaccinations begin; CDC's list will need to be winnowed to 10-20 to make the surveillance feasible, and which AEs make the cut may be informed by the vaccine trials, as well as clinical experience with COVID infections.
Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.
Getting an EUA is not a reason to vaccinate all placebo patients, US FDA officials write in NEJM article.