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 thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review.
The FDA said chronic under-collection of GDUFA revenue could create budget problems going forward unless the system is changed, but industry does not want to endanger the generic sector with higher fees.
Payroll costs in the prescription drug user fee program increased in fiscal year 2025 despite the reduction-in-force and voluntary departures, which could impact industry efforts to reduce the annual charges.
Sponsors thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review.
Agency offered to drop annual IND fees for sponsors not conducting Phase I trials in US, but industry still raised several concerns about fee incentives for onshoring clinical development.
In a signal that prescription drug and generic drug user fee talks are nearing completion, the FDA and industry are preparing to start biosimilar user fee reauthorization talks with America First and other issues potentially looming.