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.
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Latest From Derrick Gingery
Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.
What's in – and what fell out of – the massive US stimulus package.
Agency appears to have a fair bit of flexibility in how to spend the additional $80m slated for coronavirus activities.
An additional $160m is allocated to FDA in House coronavirus-related stimulus bill aimed at fighting the pandemic and helping the wobbling economy. It would not, as a similar Senate bill proposes, once again allow using pre-tax savings accounts to buy OTC drugs.
Productivity may suffer under coronavirus-mandated telework despite workforce diligence, experts say.
Unlike diagnostics, EUAs for drugs are rare and the fact that there already are FDA-approved competitors for Bayer’s chloroquine phosphate product may make the decision more complicated.