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
Model-Informed Drug Development Program Could Handle More Requests, But US FDA Needs Funding
FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.
US FDA’s CBER Seeks Associate Director Overseeing Rare Disease Work
Rare disease activities within the biologics center will gain more prominence with a senior official overseeing them.
Pink Sheet Podcast: US FDA Worries About Celebs Endorsing Drugs, Post-Chevron Lawsuits Emerging
Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion, as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned.
CDER, CBER Report More Hiring Gains, But At Slower Rate Than Earlier In Fiscal Year
Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.
Pink Sheet Podcast: What We Learned From The First Batch Of Medicare Negotiated Drug Prices
Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding.
Existing Innovative Trial Design, Endpoint Tools Could Be Help Ultra-Rare Sponsors Need
Amid a push for new incentives, the US FDA’s Kerry Jo Lee, associate director for rare diseases in the Center for Drug Evaluation and Research’s Office of New Drugs, said in an interview with the Pink Sheet that the tools ultra-rare sponsors need already are available.