Bridget Silverman
Senior Editor
Washington, D.C.
Bridget Silverman has been covering FDA for the Pink Sheet since David Kessler was commissioner. She keeps watch on the drug review process for the FDA Performance Tracker and the Drug Review Profile series. She covered FDA and financial beats as a Pink Sheet reporter before focusing on the drug development and approval process as an editor on Pharmaceutical Approvals Monthly and the NDA Pipeline, developing products that inform our current regulatory tracking features and in-depth FDA review coverage. In her down time, Bridget reads mystery novels and keeps track of her family and three dogs.
Latest From Bridget Silverman
Internal US FDA Disagreements Feature In One-Quarter Of Novel Approvals
A team led by Dalhousie University researchers examined 174 novel approvals from 2011-2015 and found 155 instances of disagreement, affecting 42 drugs.
Keeping Track: Veklury NDA Arrives At US FDA; Olinvyk Sees Approval; MAb Filings By Regneron, Y-mAbs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track: Four Novel Agents Clear US FDA, Including Evrysdi, Blenrep
The latest US FDA approvals and actions from the Pink Sheet’s US FDA Performance Tracker.
US FDA Picks Up The Pace Of Complete Response Letters Over June And July
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.
Keeping Track: The Breakthrough Designations Of Summer Eschew Phase I
The latest breakthrough therapy designation announcements from the Pink Sheet’s US FDA Performance Tracker
August User Fee Calendar Features Gene Therapy, Analgesics, And Of Course Oncology
Sixteen applications are in line for US FDA decisions in August. Ten are novel agents.