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.
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Latest From Derrick Gingery
US FDA's GDUFA-Related FTEs Increase … Except In CBER
Employees performing generic drug user fee program and related work increased nearly 68% between FY 2014 and FY 2018; Costs, as well as dependence on fees to pay for them, also increased during the period.
FDA Fights Problems With Pre-ANDA Meeting Requests
More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.
US FDA Still Fighting Problems With Pre-ANDA Meeting Requests
More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.
FDA Reports Millions In Unpaid GDUFA Fees
The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.
BIO Stalwart Greenwood Announces Departure
Long-time CEO of the Biotechnology Innovation Organization will remain until after the 2020 election and help with the leadership transition.
US FDA Reports Millions In Unpaid GDUFA Program Fees
The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.