Derrick Gingery
Executive Editor, Reg & Policy Insights, US
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
US FDA’s New Voucher Fee Reveals Standard, Priority Review Cost Spike
The number of standard and priority reviews also decreased significantly in FY 2023 compared to the previous year, which caused the fee for redeeming a voucher to rise.
Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion
US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
New AAM CEO Looking To ‘Force Multiply’ For US Generics Industry
John Murphy, who will take over the Association for Accessible Medicines in October, said in an interview that the number and types of voices advocating for the generics industry must increase.
Inflation Continues To Rear Head At US FDA User Fees
Inflation accounted for a larger portion of user fee revenue target increases for fiscal year 2025, compared to previous years, according to a Pink Sheet analysis.
Model-Informed Drug Development Program Could Handle More Requests, But US FDA Needs Funding
FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.
US FDA’s CBER Seeks Associate Director Overseeing Rare Disease Work
Rare disease activities within the biologics center will gain more prominence with a senior official overseeing them.