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
A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.
Industry representatives raised several concerns about an FDA proposal to charge additional fees to sponsors not conducting Phase I trials in the US, including that the idea could increase the burden of drug development overall.
The agency wants to ensure orphan drug sponsors cannot benefit from fee exemptions while gaining approval of non-orphan indications.
The move is intended to allow incoming acting director Tracy Beth Høeg to learn from outgoing director Richard Pazdur before he retires.
The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.
The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.