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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.
Set Alert for Articles By Derrick Gingery

Latest From Derrick Gingery Still Lacks Many Study Results, JAMA Finds; Do Transparency Efforts Need A Boost?

Industry data transparency initiatives are well-established now, but JAMA study suggests holes in efforts to publicly release clinical trial results.
Clinical Trials Research and Development Strategies

New Right To Try Bill Fails To Persuade

US House rejects tempered legislation as many stakeholders remain opposed – but vote allows members to signal to the Trump administration that they tried.

Legislation Clinical Trials

US FDA Eliminating 'Sub-Indications' From Inflammatory Bowel Disease Labels

Claims such as induction of clinical remission will now be placed in the clinical studies section for new IBD approvals.

Gastrointestinal Drug Review

Pfizer Xeljanz: Duration Of 10 mg Dose In Ulcerative Colitis Could Hinge On Post-Market Commitment

Postmarket trial looking at reduced doses in UC may be difficult to enroll, Pfizer argues; with approval of expanded indication seeming assured, another postmarket question for Xeljanz could look at impact of herpes zoster vaccine.

Advisory Committees Post Market Regulation & Studies

Gene Therapy Manufacturing Remains Large Hurdle For Development, US FDA's CBER Director Says

Scale-up in particular is a challenge and FDA wants to help lower the barrier, CBER Director Peter Marks tells rare disease conference.

Regenerative Medicine Research and Development Strategies

Xeljanz's UC Indication On Track With Higher Doses After Unanimous Advisory Committee Votes

US FDA's Gastrointestinal Drugs Advisory Committee says higher dosing regimens can be used despite agency worries about safety with long-term use.

Advisory Committees Gastrointestinal
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