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Derrick Gingery

Senior Writer

Washington, DC
Senior writer Derrick Gingery has been reporting on regulatory issues for "The Pink Sheet" and "The Pink Sheet" Daily since 2010. Among his favorite topics are FDA's user fee programs, along with generic drug and biosimilar policy, but he also handles drug approval issues and general FDA news.

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

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.

FDA Leadership

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.

Biosimilars Intellectual Property

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.

Advisory Committees Ophthalmic

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.

Drug Review FDA

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.

Biosimilars Intellectual Property

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.

Regulation Generic Drugs
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