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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: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News

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

US FDA Performance Tracker Complete Response Letters

BioMarin’s Voxzogo Accelerated Approval Based Mostly On One-Year Data

US FDA advisory committee had encouraged a two-year endpoint for achondroplasia treatments, but BioMarin attributes success to having ‘partnered closely’ with the agency. Confirmatory trial still being discussed.

Approvals Drug Approval Standards

US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain

Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

Review Pathway Drug Review

Keeping Track: Parsaclisib, Kymriah Applications Target Non-Hodgkin Lymphomas; AbbVie Gets New Use For Old Ophthalmic

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

US FDA Performance Tracker Approvals

CDC Panel Stops Shy Of Universal Adult Hepatitis B Vaccine Recommendation

ACIP working group proposal for all adults was altered to include an upper age limit for universal hepatitis B vaccination.

Advisory Committees Vaccines

Keeping Track: US FDA Approves Novartis’ Scemblix; Lilly Submits Tirzepatide, Withdraws Tanezumab

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

US FDA Performance Tracker Approvals
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