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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

Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar

Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

US FDA Performance Tracker Approvals

US FDA Calls ’Em Like Its Advisory Committees See Them

So far this year, when the agency has taken action on NMEs that went before advisory committees, the FDA decision has matched the committee vote.

Advisory Committees Drug Approval Standards

Coming Attractions: Novel Agents In Line For US FDA Decisions By Year-End

Interactive table from the Pink Sheet breaks down the 40 novel drugs and biologics have user fee goal dates before the new year.

Approvals Drug Review

Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

US FDA Performance Tracker Approvals

Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

Rare Diseases Drug Approval Standards

US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals

Comprehensive table comparing all the novel agents approved by either the US FDA or the European Commission over 2023 through April 2024.

Regional Comparisons Approvals
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