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Derrick Gingery
Senior Writer
Washington, DC
Senior writer Derrick Gingery has been reporting on regulatory issues for "The Pink Sheet" and "The Pink Sheet" Daily since 2010. Among his favorite topics are FDA's user fee programs, along with generic drug and biosimilar policy, but he also handles drug approval issues and general FDA news.
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.
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
US FDA Shuttering More Operations As User Fee Money Dwindles
Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.
Sotagliflozin: A Potential Test Of Patient-Physician Decision-Making
Sanofi's proposed type 1 diabetes treatment may be beneficial for some patients who want more glycemic control and are willing to perform the necessary monitoring, but how would the US FDA define that population in the label?
Scenes From A Shutdown: US FDA Hides It Well
FDA's two recent advisory committee meetings at its White Oak campus offer no obvious clues that agency is struggling due to dwindling carryover balances and furloughed employees.
Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee
Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.
Insulin Makers May Be First In Crosshairs Of DeGette Rx Pricing Investigation
Rep. Diana DeGette, new chair of US House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, said insulin is a good example of problems with drug pricing and promised to call drug company CEOs to hearings.
Sanofi's Oral Type 1 Diabetes Drug Approval May Hinge On Ketoacidosis Management
US FDA also questions composite efficacy endpoint used in one of the phase III trials as sotagliflozin reaches advisory committee in attempt to become first approved oral type 1 diabetes treatment. Sanofi says that type 1 diabetes patients already manage DKA risk because it is inherent to their condition and patients did not seem bothered by the instructions to handle DKA.
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