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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

US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021

The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).

US FDA Performance Tracker Approvals

Keeping Track: Breakthrough Designations Fuel Expansion Of Genomically-Defined NSCLC Therapy

News and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Review Pathway

Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.

United States Pink Sheet Perspectives

Keeping Track: Idorsia’s Quviviq Is FDA’s First Novel Approval Of 2022; AbbVie’s Rinvoq Gains Eczema Claim

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

US FDA Performance Tracker Approvals

First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year

CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.

Approvals Drug Approval Standards

US FDA’s 2021 Novel Approvals: A Closer Look

Our infographic shows the various routes that the 60 novel agents took to approval, from Real-Time Oncology Review to Qualified Infectious Disease Product designation.

Approvals Review Pathway
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