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
Rejecting FDA Advice, ACIP Defers J&J COVID Vaccine Blood Clot Decision Until It Gets More Data
US FDA suggested potential risk could be managed though a change in the fact sheet, but CDC committee wants more data, which could come within a week or so, to get a better sense of the frequency of the adverse events.
Tentative Biosimilar Approvals Under Consideration By FDA
Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.
White House Reiterates Confidence In FDA Expertise, Independence With J&J Vaccine Pause
Not only did White House and other officials support the recommendation, but also made clear they had no advance notice of it.
Can Biosimilars Compete With ‘Unbranded Biologics’ In The US Market?
Biologics with their brand name dropped from the label could become the alternative to an ‘authorized biosimilar,’ which is not allowed under the law.
Cavazzoni Helms US FDA Drug Center With OTC Monograph Reform Starting, Novel Switches Next
Patrizia Cavazzoni, who likely represents a somewhat different leadership style for CDER, distinguished herself while leading the center temporarily during the COVID-19 pandemic.
Tentative Biosimilar Approvals A Consideration for the US FDA
Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.