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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. 

Latest From Bridget Silverman

On The Docket: Recent Submissions For US FDA Approval

Round-up of late summer applications recently submitted to US FDA, adapted from the Pink Sheet FDA Performance Tracker's User Fee Goal Dates chart.

Drug Review Regulation

US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal

Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.

Cancer Review Pathway

Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA

The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Coccidioidomycosis Outlook Highlights The Limits Of Regulatory Incentives

The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.

Rare Diseases Review Pathway

US FDA Approval Activity Could Cool Down In September

With just 10 user fee goal dates coming up, September could be break from the fast pace of FDA decisions over the summer.

US FDA Performance Tracker Drug Review

Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved

The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Review
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