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Derrick Gingery

Executive Editor, Reg & Policy Insights, US

Washington, DC

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 User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.

User Fees Drug Review

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Artificial Intelligence Research & Development

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Artificial Intelligence Research & Development

‘Threading The Needle:’ Finding A Regulatory Foundation For Ultra Rare Disease Development

Sometimes even the US FDA’s regulatory flexibility may not be enough to approve rare disease treatments in very small populations, but agency officials worry that creating a new pathway could be problematic.

Rare Diseases Drug Approval Standards

Pink Sheet Podcast: Clinical Trial Reg Issues, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock

Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.

Clinical Trials Pricing Debate

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.”

FDA Advisory Committees
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