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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

ANDA Submissions Drop To Start FY2021

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

Generic Drugs Drug Review

Even As Acting US FDA Commissioner, Woodcock Still Holds Multiple Positions

To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.

FDA Leadership

Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII

User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.

User Fees Drug Safety

ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.

Generic Drugs Drug Review

COVID-19 Vaccine Distribution Confusion Grows As Eligibility Widens

President-Elect Biden also adds David Kessler and Andy Slavitt to his COVID-19 response team, retains Francis Collins at NIH director.

Distribution Coronavirus COVID-19

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

FDA Leadership
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