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.
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Derrick Gingery
New US FDA Commissioner Stephen Hahn Heads to White Oak Under Vaping Cloud
Bipartisan Senate confirmation vote comes despite concerns about Stephen Hahn's non-answers to e-cigarette regulation questions.
US Biosimilar Sponsors Seek Off-The-Record Discussions
Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.
Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions
FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.
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.