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
US FDA’s Califf Says Adcomm Votes Not Vanishing Completely
At a Senate subcommittee hearing, the FDA commissioner says advisory committees remain important but need to be “meeting the purpose for which they exist.”
Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity
US FDA Principal Deputy Commissioner Namandjé Bumpus recently attended a biotech-themed roundtable with the Senate Select Committee on Intelligence and national security officials as Congress’ pulls the FDA into its worries about Chinese influence of the pharma industry.
BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern’
But that clock is already ticking as the House Oversight and Accountability Committee prepares to mark-up the bill and a likely reconciliation effort with the Senate looming.
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.