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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. 
Set Alert for Articles By Bridget Silverman

Latest From Bridget Silverman

Keeping Track, Oncology Edition: Biologic Breakthroughs And BLAs

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

US FDA Performance Tracker Cancer

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

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

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

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

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

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

US FDA Performance Tracker Research & Development

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

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

US FDA Performance Tracker Approvals

Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.
Neurology Drug Approval Standards
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