Bridget Silverman
Managing Editor, US Regulatory Analysis
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.
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.
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.’
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.
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.
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.