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.
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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.
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.
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.
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 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.
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.