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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

Evolution In Clinical Outcome Assessments Reflected In US FDA’s Revised Gastroparesis Guidance

Agency recommends an anchor-based approach to statistical analyses of drug effects on core signs and symptoms.

Drug Approval Standards Clinical Trials

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

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

Mustang Bio Joins RMAT List; Eiger Brings Home Its 4th BTD

Gene therapy and lambda interferon products are highlighted in the new Review Pathways section of the US FDA Performance Tracker, which keeps track of breakthrough therapy (BTD), regenerative medicine advanced therapy (RMAT), qualified infectious disease product (QIDP) designations and biosimilar submissions.

Rare Diseases Review Pathway

Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients

US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.

Drug Approval Standards Cardiovascular

Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD

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

US FDA Performance Tracker Approvals

Full Pediatric Labeling Is Lacking For One Third Of Orphan Drugs, US FDA Finds

The past three years have seen an increase in number of orphan drug labels containing appropriate pediatric information.

Approvals Rare Diseases
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