Derrick Gingery
Senior Writer
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.
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.
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.
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.
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.
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.