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.
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Latest From Bridget Silverman
Keeping Track: Rebuff Of Iclaprim Creates Early Pileup Of CRLs For Novel Drugs
The latest drug development news and highlights from our US FDA Performance Tracker.
Novartis’ Attention To Tropical Diseases Pays Off: Liver Fluke Drug Egaten Earns Priority Review Voucher
US FDA approval expected to facilitate global use of one-day oral treatment of fascioliasis, a designated neglected tropical disease, which Novartis developed with the World Health Organization.
Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer
Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
Keeping Track: FDA Approves First Generic Advair, But Alkermes And Sunovion Land CRLs
The latest drug development news and highlights from our US FDA Performance Tracker.
Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.
Keeping Track: Bad News For Bristol And Lilly, Good News For TG Therapeutics
The latest drug development news and highlights from our US FDA Performance Tracker.
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