Managing Editor, US Regulatory Analysis
Latest From Bridget Silverman
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.
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.
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.’
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.
Takeda hopes for good news on fruquintinib and TAK-755, while Bristol and SpringWorks share a goal date for their breakthrough-designated cancer treatments.
Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.