Derrick Gingery
Executive Editor, Reg & Policy Insights, US
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
Califf Says US FDA Ready If Human Avian Flu Infections Jump
The FDA commissioner said an H5N1 vaccine can be developed from the same mRNA platform used to create the COVID-19 vaccines, but funds are needed to ensure production can begin quickly if a human outbreak occurs.
US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall
After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.
US FDA Developing Model Master File System To Grow Modeling, Simulation Field
Similar to drug master files, MMFs would allow models to be reused, but critical issues, such as protection of proprietary information, still must be resolved.
US FDA’s Vaccine Office Emerges From Non-COVID-19 Backlog
The Office of Vaccines Research and Review's delayed receipt policy ended in 2023, but took another two months to fully unwind, Director David Kaslow said.
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire
Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.
Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director
Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.