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
Cavazzoni, who led the drugs center four-and-a-half years, decided on her own to retire at this time, sources said. The decision may have been a preemptive move knowing her time as head of CDER would have been limited, or at the very least highly challenging, under the new administration.
Amid complaints about the challenges of following gene therapy patients for up to 15 years, OTP Director Nicole Verdun said the FDA is considering how to conduct long-term postmarket studies more efficiently.
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.
President-elect Trump is backing a government funding bill that cuts pharma priorities, but it remains unclear whether the plan will garner enough votes to prevent a government shutdown.