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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

Right-To-Try Bill Heads To White House, Putting Firms In Driver's Seat

Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.
Legislation Clinical Trials

House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule

Congress is 'very concerned' about potential final rule that would move to electronic labeling in lieu of paper distribution with prescriptions.
FDA Legislation

Should US FDA Refuse Approval If Women Under-Represented In Clinical Trials?

Idea suggested during 'Great Debate,' but agency official says no adlibbing is allowed in the regulations.

Drug Review Research and Development Strategies

US FDA's Complex Trial Design Pilot Might Be Handicapped By Disclosure Requirements

FDA wants to publicize some aspects of designs accepted into pilot, which might discourage industry participation.

 

United States FDA

Gottlieb's 2018 Generic Drug Approval Goal May Be In Doubt

Thanks in large part to new elemental impurities requirements, ANDA approvals are behind the pace needed to beat 2017’s record.

FDA Generic Drugs

US FDA, USP Collaborate To Promote Generic Development In Reversal Of Biosimilar Clash

Talks remain in early stages, but both sides thinking 'outside the box' to come up with potential policy updates to generate more generic competition and bring down drug prices.
Generic Drugs FDA
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