Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Foc ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Euro Roundup: EMA officials argue against making single pivotal trials the ‘rigid, default position’
Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a ...
Left to right: Tyler Vandivort, Patricia Ha, Marie Lemper, Corinne de Vries, and Lorna Ewart spoke at the 2026 RAPS Convergence conference. (credit: Ferdous Al-Faruque) CHARLOTTE, NC — While new ...
Left to right: Susan Stewart, Jethro Ekuta, Sonday Kelly, Zehra Tosun, Tasneem Keshavji, Jennifer Albert, Iliana Valencia, Sabine Haubenreisser, Alberto Gañan Jimenez, Corinne de Vries, Andrea Laslop, ...
Pharmaceutical industry groups largely support the US Food and Drug Administration’s (FDA) proposed rule on distributed manufacturing but are seeking clarification on how the proposed model would ...
Consumer health groups urged the US Food and Drug Administration (FDA) to allocate more resources for testing generic drugs and to implement stricter metrics for postmarket safety reporting at a ...
Singapore’s Health Sciences Authority (HSA) has expanded regulatory reliance and cooperation activities with partners in Africa, Asia, and Europe. HSA unveiled new agreements with the African ...
The US Food and Drug Administration (FDA) plans to replace terminology related to animal testing with broader terms, such as “nonclinical tests” and “nonclinical studies” throughout its regulations to ...
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