Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Bridget Silverman

Managing Editor, US Regulatory Analysis

Washington, DC
Bridget joined the Pink Sheet during the very first US Prescription Drug User Fee Act cycle and has maintained a focus on the US FDA’s drug review and approval process. Her role as managing editor of US regulatory analysis builds on her long experience at the Pink Sheet and its earlier affiliated publications Pharmaceutical Approvals Monthly and the NDA Pipeline. She oversees the Pink Sheet’s US FDA Performance Tracker suite of regulatory data, which also inform her coverage of drug development and clinical trial design. Bridget he is always interested in seeing how regulatory policy works out in practice and contributes to the Pink Sheet’s Drug Review Profile series. Outside of work, Bridget keeps track of her family, three dogs, and ever-expanding library of mystery novels.

Latest From Bridget Silverman

Keeping Track: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA

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

Approvals Review Pathway

Keeping Track: New Claims For Tukysa, Brukinsa; US FDA Wants More Patients To Support Donanemab, Pediatric Airsupra Bids

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

US FDA Performance Tracker Approvals

FDA’s Novel Approvals Again Led By Oncology And Neurology, But Dermatology Also Shone In 2022

Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.

Pink Sheet Perspectives Approvals

Keeping Track: A Blizzard Of Submissions At The US FDA

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

US FDA Performance Tracker Drug Review

US FDA’s Use Of CRLs Hit A High Note In 2022: One-Third Of Novel Agent Decisions Were Not Approvals

Pink Sheet infographic details the 20 complete response letters the US FDA issued for novel agents last year.

Pink Sheet Perspectives US FDA Performance Tracker

With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

Approvals Drug Review
See All
UsernamePublicRestriction

Register