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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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Pink Sheet reporters discuss a Duchenne muscular dystrophy drug's denial by US FDA, the administration's attempt to revive the DTC price disclosure rule, and the Business Roundtable's new principles on corporate values.
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Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.

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Pink Sheet reporters review Novartis' latest response to Zolgensma data manipulation, discuss ICER reviews of Sarepta's Duchenne muscular dystrophy treatments, and recap the FDA's latest antibiotic approval.

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Frontiers In Real-World Evidence: US FDA Partners With Syapse To Explore Sources Beyond Electronic Records

Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine.

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Another US FDA Approval Record: ANDAs Set A New Annual High Mark In Only 10 Months

Office of Generic Drugs has granted full approvals to more than 800 ANDAs in fiscal year 2019, exceeding the previous mark reached in FY 2018.

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Daiichi Must Follow Turalio Patients For 10 Years To Assess Liver Safety

As the US FDA suggested during its advisory committee review, a long-term safety study is among the postmarketing commitments for the tenosynovial giant cell tumor treatment.

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