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.
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
Rx Spending Growth To Be Driven By New Drug Entries, CMS Says
Advances in cancer, diabetes, and Alzheimer's could lead to expensive new treatments, contributing to spending increases in next decade, according to CMS projections.
Rare Pediatric Disease Priority Review Voucher Not Generating New Drug Trials
Researchers find no significant difference in number of rare pediatric disease treatments starting clinical development before or after incentive was created, but advocates aren't ready to give up on the program yet.
Competitive Generic Therapies Get Help With Development, But Not Goal Date
Draft guidance says US FDA will try to expedite assessment of competitive generic therapy designees, but will not give shorter review goals.
ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity
Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.
Nearly 9% FY 2019 Increase For FDA In Shutdown-Averting Appropriations Bill
Consolidated Appropriations Act gives FDA $5.58bn overall, 8.7% more than allocated in FY 2018. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds. FY 2019 funding would have lapsed Feb. 16 and another government shutdown would have started if President Trump didn't sign the bill on Feb. 15.
Checkpoint Inhibitors: US FDA Wants Consistent Adverse Event Definitions
Label writing is difficult because sponsors are collecting varying adverse reaction data, agency officials say.
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