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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

Biosimilar Post-Approval Change Guidance Coming From US FDA

Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.

Manufacturing Biosimilars

Disease-Free Survival In Renal Cancer Raises Questions, But Still Acceptable, ODAC Says

Whether the endpoint can predict overall survival remains unknown, but there is no evidence not to accept it, US FDA advisory committee says.

Advisory Committees Clinical Trials

Pfizer's Sutent Expanded Indication: 'Hope' Or 'False Hope'?

US FDA Oncologic Drugs Advisory Committee casts tie vote on proposed expansion of Sutent's renal cell carcinoma indication, mirroring debate FDA having internally.

Advisory Committees Cancer

FDA Towers At White Oak? High-Rises Could Help Solve Space Problems

20- and 14-story office buildings among options to expand US FDA's White Oak headquarters.

FDA BioPharmaceutical

Pfizer v. Pfizer: Sutent Indication Expansion Will Hinge On Conflicting Trials

US FDA's Oncologic Drugs Advisory Committee will consider whether positive S-TRAC or negative ASSURE data should guide decision on expanding Sutent's renal cell carcinoma indication.

Advisory Committees Cancer

Biosimilar User Fees Discounted To Begin Second Round

After adjusting for expected workload, US FDA reduces biosimilar user fee revenue target, which lowered application fees.

Biosimilars Review Pathway
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