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Derrick Gingery

Senior Writer

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

New US FDA Genetic Metabolic Adcomm Needs More Candidates

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

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US FDA’s Pazdur Wants Clinicians To Help Set Oncology Research Agenda

Oncology Center of Excellence director said clinical trial participation may increase if the research questions are ‘significant to answer.’

Cancer Clinical Trials

US FDA Should Reload Field Force To Target OTC Adulteration, Former Chief Counsel Hutt Says

Habitually noncompliant companies are laughing at FDA, Peter Barton Hutt says.

FDA Enforcement

Could NIH Help US FDA Answer More Postmarketing Questions?

FDA Commissioner Robert Califf said pharma should not be the sole entity handling postmarket research.

Clinical Trials Post Market Regulation & Studies

Artificial Intelligence Oversight At FDA Will Require Continuous Algorithm Validation, Califf Says

US FDA commissioner says stakeholders could help write AI regulations, but the agency would retain the final say of which to implement. FDA cannot regulate artificial intelligence for decision support, but can be involved when algorithms could impact patient safety.

Artificial Intelligence Regulation

Educating Congress Becomes More Essential For FDA With Key Capitol Hill Departures

Energy and Commerce Committee Chair Cathy McMorris Rodgers’ decision not to seek reelection may mean FDA officials must orient a new chair on their activities and priorities.

FDA Politics
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