Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Drug Review Drug Approval Standards

Gene Therapy Approvals By US FDA Could Double In 2020

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.

Gene Therapy Drug Review

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Approvals Drug Review

Vaccines Boost Priority Profile Of US FDA’s Biologic Center 2019 Approvals

Tropical diseases were not neglected by the Center for Biologics Evaluation and Research in 2019, producing three novel vaccines (which earned three priority review vouchers) and tilting the approval class toward expedited review programs.

Vaccines Pink Sheet Perspectives

Neuroscience Challenges Oncology For Top Spot In CDER’s 2019 Novel Approvals

Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.

Review Pathway Pink Sheet Perspectives

A Decade Of Novel CDER Approvals, By The Numbers

Pink Sheet infographic illustrates new drug approval trends and highlights from the past decade at the US FDA. 

Approvals Drug Review
See All
UsernamePublicRestriction

Register