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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

Priority Review Vouchers Post Lower Average Approval Times Than Priority NMEs

US FDA’s priority review voucher program delivers for most sponsors, a Pink Sheet analysis finds; PRVs reliably produce faster approval than priority-reviewed new drugs overall.

Review Pathway Regulation

Signs Of Life In The Bacterial Vaginosis, Vulvovaginal Candidiasis Pipeline

Scynexis highlights enrollment exceeding expectations in Phase III VVC trials; Daré prepares to enter Phase III to treat BV.

US FDA Fulfills Annual Antibiotic Guidance Goal With Three Women’s Health Guidances

Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.

Drug Approval Standards Infectious Diseases

Keeping Track: Scenesse, Reyvow, and Beovu Make Trio Of Novel Approvals

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

One Patient, Many Questions: Milasen ‘N of 1’ Trial Provides Early Template For Individualized Genomic Medicine

Rapid development of patient-customized oligonucleotide at Boston Children’s Hospital suggests promise and hazards of new drug development model.

Drug Approval Standards Rare Diseases

BeyondSpring’s Pivotal NSCLC Trial For Plinabulin Designed To Avoid Bavencio’s JAVELIN 200 Failure

Lessons learned about blinding and stratification from Pfizer and Merck KGaA’s earlier Phase III disappointment shaped the design of BeyondSpring's ongoing Phase III trial of plinabulin in second- and third-line non-small cell lung cancer.

Clinical Trials Cancer
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