Derrick Gingery
Senior Writer
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 Standard Application Assessment Makes A Comeback
After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.
Gene Therapy: Nonclinical Questions Do Not Seem Ideal For The US FDA’s New Type D Meeting
Nonclinical testing questions should be answered in a pre-IND meeting, rather than the new Type D session. A US FDA Center for Biologics Evaluation and Research official also indicated support for alternatives to animal testing when possible.
Preparing For A Shutdown: US FDA To Retain 81% Of Workforce, Thanks Mostly To User Fees
However, user fee carryover balances will not last forever and service cuts are inevitable if a shutdown lingers for several weeks.
FDA Gene Therapy Office Chief Prefers Flexibility With Accelerated Approval Confirmatory Trials
Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.
Generics Savings Once Again Could Help A Major US Health Care Reform Bill
A provision in the pending legislation on PBMs that would allow the US FDA to provide qualitative and quantitative information to ANDA sponsors about reference product's inactive ingredients could save hundreds of millions in spending.
Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon
US FDA’s biologics center intends to ask for volunteers to help demonstrate the concept, modeled on the COVID vaccine effort, which includes speedier communication with sponsors to expedite development of products for rare diseases.