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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

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  • Analysis

Novartis And The Medicines Company: Five Things To Worry About

By Bridget Silverman

The $9.7bn acquisition hinges on the small interfering RNA inclisiran, but an ongoing cardiovascular outcomes trial, manufacturing hurdles, and reimbursement challenges provide subjects for concern.

M & A Reimbursement
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  • News

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

By Bridget Silverman

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

US FDA Performance Tracker Cancer
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  • Analysis

Real-World Database Studies: Prepare For A Long Journey, IQVIA Advises

By Bridget Silverman

Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows.

Real-World Evidence Research & Development
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  • News

Keeping Track: Submissions From Alkermes, Samsung Bioepis; BTDs for Orphazyme and Kiniksa

By Bridget Silverman

The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Drug Review
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  • News

Keeping Track Of Review Designations: BTDs For X4, F2G, And BMS; Another QIDP For Allergan

By Bridget Silverman and Michael Cipriano

The latest news about products accepted into US FDA expedited review programs.

US FDA Performance Tracker Research & Development
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  • News

Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals

By Michael Cipriano and Bridget Silverman

The latest news on US FDA user fee decisions and submissions to the agency.

US FDA Performance Tracker Approvals
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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