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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

Opioid Blister-Pack Mandate Tops On Gottlieb's Agenda With New Authority

US FDA Commissioner says mandate for unit-of-dose packaging for opioids coming soon, but also acknowledges that move may make the drugs more expensive.
Neurology FDA

US FDA's Ostroff, Twice An Acting Commissioner, Retiring Next Year

A former Walmart executive will replace the deputy commissioner for foods and veterinary medicine, who spent nearly 15 months total as acting commissioner.

FDA Leadership

US FDA Appoints Another Orphan Products Development Office Head Amid Growth Expectations

Janet Maynard will become acting Office of Orphan Products Development director at the end of October, the fourth head of the office in the last 10 months; staff is expected to grow and may begin to provide development advice.
FDA Rare Diseases

US FDA Sets Generic Approval Record, But Generic Sponsors Aren't Celebrating

FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.
Generic Drugs Pricing Debate

Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting

Nearly all adverse event reports received by US FDA include brand name of biosimilar, raising questions as to whether suffix on nonproprietary name is necessary for pharmacovigilance.
Biosimilars Drug Safety

VA Changes Infliximab Biosimilars; Merck Formulary Win Could Drive Questions On Patient Switching

Move from one infliximab biosimilar to another could illuminate safety concerns surrounding non-medical switching – or at least Janssen hopes so; VA's national formulary moved from Remicade to Pfizer's Inflectra in 2017.
Biosimilars Pricing Debate
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