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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

Culture Wars Reach Labeling For COVID-19 Treatments

Senators ask US FDA to change statements in COVID-19 monoclonal antibody fact sheets that factors like race or ethnicity may place a patient high-risk of serious illness, saying they promote racist decisions.

Diversity & Inclusion Coronavirus COVID-19

Pink Sheet Podcast: Aduhelm Medicare Coverage, Fewer FDA Adcomms, Domestic Drug Production Effort

Pink Sheet reporter and editors discuss the CMS coverage decision for Biogen and Eisai’s Alzheimer’s treatment Aduhelm, the FDA conducting fewer advisory committee meetings in 2021 and the Defense Department’s efforts to increase domestic drug production.

Neurology Advisory Committees

Janssen COVID-19 Vaccine Adds Another Thrombotic Warning

US FDA adds a warning about immune thrombocytopenia, joining the risk of Thrombosis with Thrombocytopenia Syndrome.

Coronavirus COVID-19 Vaccines

CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave

A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.

FDA Gene Therapy

‘Most People Are Going To Get COVID’: US FDA’s Woodcock Not Ready To Shift To Endemic Policy

Acting FDA commissioner tell Senate committee that federal priority should be to ensure essential services remain functional as the Omicron variant’s spread continues.

Coronavirus COVID-19 Vaccines

With Many More COVID-19 Vaccine Changes Ahead, ACIP Expecting Fewer Public Meetings

CDC’s Advisory Committee on Immunization Practices wants a more feasible and sustainable meeting schedule in 2022, which would reduce transparency.

Advisory Committees Coronavirus COVID-19
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