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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

US FDA Struggles To Meet Goals As Drug Sponsors' Meeting Requests Rise

The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.

Review Pathway FDA

Assessment Times Improve Under GDUFA

Averages likely will increase as more of the cohort is approved, however.

Generic Drugs Regulation

Pink Sheet Podcast: Upcoming Opioids Policy Meeting, Improving US FDA's Rare Disease Legalese

Pink Sheet reporters discuss the proposed US opioid lawsuit settlement, Public Citizen's opioid citizen petition denial, and the upcoming US FDA public meeting on opioid standards, as well as a proposal to better outline agency flexibility with rare disease drugs.

Drug Approval Standards Neurology

Everything's Special At US FDA: Priority NDA/BLA Filings Surge

The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.

Drug Review Regulation

Generic Drug Assessment Times Show Improvement In GDUFA Performance Report

Averages likely will increase as more of the cohort is approved, however.

Generic Drugs Drug Review

US FDA's New Drug Assessors More Experienced With Rare Disease Issues

Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.

Drug Approval Standards Rare Diseases
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