Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, we ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Foc ...
The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation. Hailed by the government as a ...
FDA looks for evidence behind the corrective action Many companies recalled product, opened corrective and preventive actions (CAPAs), revised procedures, submitted records, or wrote to FDA more than ...
Left to right: Stiina Aarum, Corinne de Vries, Andrea Laslop, Alberto Gañán Jiménez, and Sabine Haubenreisser spoke at RAPS Convergence 2026. (credit: Ferdous Al-Faruque) CHARLOTTE, NC – A panel of ...
The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the ...
Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of ...
The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA ...
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