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
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.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?
EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.
Rare Cancer Development Consortium Moving Toward Target Selection
An upcoming public meeting will include a look at platforms before the first targets are chosen.
Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger
The Barth Syndrome candidate application will be reviewed by the FDA, but Stealth BioTherapeutics' CEO tells the Pink Sheet that the company still does not have clear guidance on how or whether it should gather additional clinical data.