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
Pink Sheet Podcast: Merck’s Frazier Speaks Out, US FDA’s Hahn On Decisions, Operation Warp Speed, Worries About User Fee Goal Delays
Pink Sheet reporters and editor discuss Merck CEO Ken Frazier’s thoughts on racial inequity, FDA Commissioner’s explanation of coronavirus decision-making and Operation Warp Speed changes, and consider fears about the potential for user fee goal delays.
EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.
The FDA wants to know if the second letter in its product equivalence ratings system is helpful and whether changes could make the information more user-friendly.
Request for documents and a briefing is part of efforts to ensure federal programs are ‘protected from price gouging.’
New Q&A guidance also states that its near-term focus for resources will be on coronavirus and some other conditions.
The agency wants to know if the second letter in the product equivalence ratings system is helpful and whether changes could make the information more user-friendly.