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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

Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected

Horizon CEO says safety trial will be conducted in a larger patient population following discussions during the US FDA advisory committee meeting.

Post Market Regulation & Studies Approvals

Complex Generic Approval Delays Getting Congressional Attention

US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.

Generic Drugs Legislation

December ANDA Rush Is Largest In Two Years

December's ANDA rush has provided the largest monthly haul in two years. However, the month may be losing its influence over the US FDA's annual submission total.

Regulation Generic Drugs

Opioid-Sparing Hopes, Efficacy Worries Drive Inconclusive Advisory Cmte. On Durect's Posimir

US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.

Advisory Committees Drug Review

December ANDA Rush Is Largest Monthly Haul In Two Years

However, the month may be losing its influence over the US FDA's annual submission total.

Generic Drugs Review Pathway

Sharfstein: US FDA Incentives Not Broke, But Fix Them

The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.
Drug Review Research and Development Strategies
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