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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 Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest'
Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.
Biosimilar Sponsors Want Off-The-Record Labeling Discussions With US FDA
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions written record; negotiations for BsUFA III may be opportunity to create such a process.
ANDA Approval Records Likely To End
CDER director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
ANDA Approval Records Will End As US FDA Mops Up Backlog
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
Commissioner Nominee's Required Divestitures Illustrate US FDA's Broader Recruitment Challenge
Stephen Hahn will have over 100 stocks to divest upon becoming FDA commissioner.
Missed ANDA Nods Mostly Due To 'Imminent Approval'
US FDA will miss goal dates to reach speedier generic drug application approvals, but says decisions will be case by case.