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
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
US FDA Hopes Food, Inspection Office Reorg Bolsters Innovative Clinical Trial Adoption
Ensuring inspectors understand the innovative trial designs in use before an inspection will be important to increasing industry confidence in their use, CDER Director Patrizia Cavazzoni said.
US FDA's CDER Creates Quantitative Medicine Center Of Excellence; Job Includes AI Oversight
The group will coordinate quantitative medicine issues throughout the FDA's Center for Drug Evaluation and Research to help streamline drug development.
Pink Sheet Podcast: Mifepristone And Misinformation At SCOTUS, Understanding US FDA’s ODAC
Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access, the SCOTUS reaction to the fight against misinformation, and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews.
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.
Gene Therapy Sponsors Claim US FDA ‘Processing Error’ Could Cause Delays
Office of Therapeutic Products Director Nicole Verdun says the problem is uncommon and sometimes relates to missing manufacturing information.