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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

FDA Search For CDER Deputy Emphasizes 'Executive Direction'

An M.D. is preferred for position that would run CDER in director's absence and oversee 'major programs' at the Center.

FDA Leadership

Moscicki's Move From FDA To PhRMA About 'Best' Use Of Leadership Skills

At inconveniently timed NORD conference, the former CDER deputy center director finds himself unable to speak for either FDA or the Pharmaceutical Research and Manufacturers of America.

FDA Leadership

Keytruda's New Tissue-Agnostic Indication Could Prompt Orphan Policy Changes

US FDA contemplating how to match orphan designation process with drug development moving to molecularly-targeted therapies.

Rare Diseases Review Pathway

Aerie's Netarsudil Headed For Broad Indication With Only Subpopulation Efficacy

US FDA's Dermatologic and Ophthalmologic Drugs Advisory Committee votes in favor of efficacy of proposed glaucoma treatment, but several say only in patients with baseline intraocular pressure less than 25 mmHg.

Advisory Committees Ophthalmic

Aerie's Netarsudil's Safety Questions May Determine Fate At Advisory Committee

Proposed treatment for elevated intraocular pressure would be first in new rho-associated protein kinase inhibitor class.

Advisory Committees Ophthalmic

FDA Web Portal Eases Pre-ANDA Meeting Request Process

New CDER Direct NextGen Collaboration Portal allows sponsors of complex ANDAs to submit and track formal meeting requests.

FDA Generic Drugs
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