Derrick Gingery
Senior Writer
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.
Latest From Derrick Gingery
Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research
ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.
US FDA and ARPA-H: Woodcock Has Questions
The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.
Woodcock Focusing On Food Issues, Rather Than Drugs, As US FDA’s Principal Deputy Commissioner
Commissioner Robert Califf wants Woodcock to improve food operations and processes, but lawmakers question whether she is the best overseer for the area.
Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval
Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.
Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.