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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
Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.
Whether the endpoint can predict overall survival remains unknown, but there is no evidence not to accept it, US FDA advisory committee says.
US FDA Oncologic Drugs Advisory Committee casts tie vote on proposed expansion of Sutent's renal cell carcinoma indication, mirroring debate FDA having internally.
20- and 14-story office buildings among options to expand US FDA's White Oak headquarters.
US FDA's Oncologic Drugs Advisory Committee will consider whether positive S-TRAC or negative ASSURE data should guide decision on expanding Sutent's renal cell carcinoma indication.
After adjusting for expected workload, US FDA reduces biosimilar user fee revenue target, which lowered application fees.