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
ClinicalTrials.gov Still Lacks Many Study Results, JAMA Finds; Do Transparency Efforts Need A Boost?
US House rejects tempered legislation as many stakeholders remain opposed – but vote allows members to signal to the Trump administration that they tried.
Claims such as induction of clinical remission will now be placed in the clinical studies section for new IBD approvals.
Postmarket trial looking at reduced doses in UC may be difficult to enroll, Pfizer argues; with approval of expanded indication seeming assured, another postmarket question for Xeljanz could look at impact of herpes zoster vaccine.
Scale-up in particular is a challenge and FDA wants to help lower the barrier, CBER Director Peter Marks tells rare disease conference.
US FDA's Gastrointestinal Drugs Advisory Committee says higher dosing regimens can be used despite agency worries about safety with long-term use.