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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

Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer

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

US FDA Performance Tracker Approvals

Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

US FDA Performance Tracker Drug Review

Keeping Track: New Formulations Dominate In CNS; Immunocore Brings First TCR Therapy To US FDA

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

US FDA Performance Tracker Approvals

Keeping Track: Breakthroughs Of Summer Break Ground In Psychiatry, Cancer (Especially Nasopharygeal Cancer) And Vaccines

US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.

US FDA Performance Tracker Review Pathway

Stealth Elamipretide NDA Tests Frontiers Of US FDA’s Flexibility In Rare Diseases

FDA wants another trial in ultra-orphan Barth syndrome, but could not identify a feasible design – so Stealth submitted the NDA anyways, based on a retrospective natural history control trial

Rare Diseases Drug Approval Standards

US Vs EU: First Half 2021 Novel Approval Scorecard

The Pink Sheet's table of the 55 novel products approved in either the US or EU during H1 2021 includes details on approval dates, use of special review pathways and review status such as orphan product or priority review.

Approvals Review Pathway
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