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Derrick Gingery

Senior Writer

Washington, DC
Senior writer Derrick Gingery has been reporting on regulatory issues for "The Pink Sheet" and "The Pink Sheet" Daily since 2010. Among his favorite topics are FDA's user fee programs, along with generic drug and biosimilar policy, but he also handles drug approval issues and general FDA news.

An award-winning journalist, Derrick has written extensively about user fee negotiations, the FDA budget, FDA travel restrictions and drug advertising compliance. He also was part of the Pink Sheet team covering FDA's first biosimilar advisory committee meetings.

When he's not following FDA, Derrick is keeping close tabs on Indiana Hoosiers basketball.

Latest From Derrick Gingery

US FDA Likely To Embrace In-Person, Remote Combo For Facility Inspections Going Forward

The system likely will evolve as the post-pandemic world unfolds, but adds to the list of agency programs expecting to continue using virtual platforms once in-person activities are no longer restricted by COVID-19.

Manufacturing Coronavirus COVID-19

US FDA/Industry Thinking PDUFA VIII Could Be A Hybrid Negotiation

Virtual meetings proved successful, and could be allowed again when the next round of user fee reauthorization talks convene.

User Fees Legislation

Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products

The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.

Clinical Trials Research & Development

Califf Floats Third-Party Supply Chain Monitoring To Fight Product Shortages

The US FDA commissioner’s call for the agency or someone else to watch supply chains and anticipate problems sounds a lot like a generics industry idea from 2011.

Manufacturing Supply Chain

Novavax’s Pending EUA Likely Less Important Than Future Updates

Upcoming booster, adolescent data may be more commercially significant for the vaccine, which would enter a US market with few willing adults still unvaccinated. The tough prospects for one of the first COVID vaccines in development is a lesson in the importance of avoiding regulatory delays.

Coronavirus COVID-19 Vaccines

Is A Class-Wide Myocarditis Warning Coming For COVID-19 Vaccines?

Now that multiple vaccines using different platforms seem to be associated with heart inflammation, the FDA and others want more data on whether a common characteristic of the virus or vaccine manufacturing is related.

Coronavirus COVID-19 Vaccines
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