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
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.
The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.