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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

Coronavirus Sponsors Should Get Responses To Regulatory Requests Within One Day, US FDA Says

As part of the new Coronavirus Treatment Acceleration Program, FDA staff also are being reassigned to handle investigational therapy requests faster.

Coronavirus COVID-19 Drug Review

Coronavirus Demanding Focus Of US FDA’s Antiviral, Other Divisions

Office of New Drugs Director Peter Stein said in an interview that a large amount of coronavirus-related work is arriving at the FDA, but so far staff are keeping up.

Coronavirus COVID-19 Drug Review

US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework

Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.

Coronavirus COVID-19 Drug Review

Inside The COVID-19 Bill: Breaking Down The Pharma Policy Provisions

What's in – and what fell out of – the massive US stimulus package.

Coronavirus COVID-19 Legislation

US FDA Would Get Funding Boost Under House Coronavirus Stimulus Bill

Agency appears to have a fair bit of flexibility in how to spend the additional $80m slated for coronavirus activities.

Coronavirus COVID-19 Legislation

More FDA Funding In House Coronavirus Stimulus Bill, But No OTC Purchases With Pre-tax Savings

An additional $160m is allocated to FDA in House coronavirus-related stimulus bill aimed at fighting the pandemic and helping the wobbling economy. It would not, as a similar Senate bill proposes, once again allow using pre-tax savings accounts to buy OTC drugs.

Coronavirus COVID-19 FDA
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