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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.

Latest From Derrick Gingery

Biden Leaves US FDA Largely Out Of Budget Outline

FDA is only mentioned once in the document, and its temporary leadership may not be the reason why.

FDA Legislation

Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

Coronavirus COVID-19 Review Pathway

FDA, CDC Leaders Under Trump Urge Fixed Terms For US Health Agency Heads

Former FDA Commissioner Stephen Hahn and former CDC Director Robert Redfield said leaders of their agencies and NIH  should be selected outside the election schedule. White House task force reviewing political interference with agency science.

FDA Leadership

PDUFA VII Could Increase Transparency Of REMS Release Process

Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.

User Fees Risk Management

The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined

Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.

Coronavirus COVID-19 Research and Development Strategies

Inspection Questions Delay CBER’s Embrace Of Real-Time Oncology Review

The oncology branch of the US FDA’s biologics center does not believe RTOR would speed application reviews.

Biologics Review Pathway
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