Derrick Gingery
Senior Writer
Derrick focuses on the US FDA user fee programs, regulations and policy for new and generic drugs, biologics and biosimilars, advisory committee and other agency activities, as well as federal legislation and budget matters on Capitol Hill. He also hosts Pink Sheet's Pharma Regulatory Podcast. An award-winning journalist, Derrick has been a reporter for several community newspapers and a business journal. When not following FDA, Derrick is keeping close tabs on Indiana University basketball.
Latest From Derrick Gingery
CDER, CBER Post FY 2023 Employee Gains, But Behind User Fee Hiring Goals
US FDA’s drug center reported a net increase of more than 300 employees in FY 2023, while the biologics center saw an overall increase of more than 30.
Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.
Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development
Cross-center AI strategy features collaboration between drug, biologic, device and combination product staff to ensure regulatory predictability. ‘Assurance labs’ offering independent valuation of models should be available by year-end as part of FDA’s involvement with Coalition for Health AI.
US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’
Advisory committee reform efforts include streamlining the selection and onboarding processes, in part to understand that members often have other professional priorities, Principal Deputy Commissioner Namandjé Bumpus said.
Imetelstat Scores Positive ODAC Nod Thanks To Quality Of Life Improvement
Responders to Geron’s proposed anemia treatment could see weeks-long breaks between transfusions, which Oncologic Drugs Advisory Committee members said outweighed efficacy and safety issues.
US FDA Wants Advisory Committee Duty To Be ‘Enjoyable’
Advisory committee reform efforts include streamlining the selection and onboarding processes, in part to understand that members often have other professional priorities, Principal Deputy Commissioner Namandjé Bumpus said.