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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

US FDA’s Sentinel System Strives To Stay Ahead Of Its Own Success

The sprawling safety surveillance system is propelling advances in informatics and advanced analytics, but the agency is delaying next contracting cycle to digest its experience.

Drug Safety Post Market Regulation & Studies

Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023

AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.

US FDA Performance Tracker Approvals

Antiretroviral Pregnancy Registry Lights Way For Pregnancy Postmarketing Studies

The 30+ year-old program, which monitors prenatal exposure to 164 drugs, should be the template for other efforts, US FDA officials say, because disease-based pregnancy registries ‘have a better track record.’

Post Market Regulation & Studies Women's Health

Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.

Regional Comparisons Drug Review

November US FDA User Fee Calendar: Takeda On Tap; Small Molecules For Cancer

Takeda hopes for good news on fruquintinib and TAK-755, while Bristol and SpringWorks share a goal date for their breakthrough-designated cancer treatments.

US FDA Performance Tracker Approvals

Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short

Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.

US FDA Performance Tracker Drug Review
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