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
Sponsors also want efficacy supplement action packages released after redaction as part of a proposal to increase first-cycle approvals.
FDA officials want to charge the generic drug program fee per ANDA owned going forward, rather than the current practice of separating firms into different fee-paying tiers based on the number of ANDAs owned.
Pink Sheet editors discuss the average speed of FDA novel drug application reviews in 2025 and consider whether staffing departures and general upheaval throughout the year will impact times in 2026.
The agency indicated during prescription drug user fee reauthorization discussions about performance metrics that 20% of reviewers were lost last year.
Pink Sheet editors discuss Richard Pazdur’s concerns about the Commissioner’s National Priority Voucher program and the idea that the FDA could release action packages for unapproved products in addition to complete response letters.
The plan does not include many details, but is intended to help Congress draft legislation ensuring Most Favored Nation drug pricing agreements can be made, as well as implement measures intended to lower insurance premiums.