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
To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
President-Elect Biden also adds David Kessler and Andy Slavitt to his COVID-19 response team, retains Francis Collins at NIH director.
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
The proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.