Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
The EU Medical Device Regulation (MDR) has certainly caused significant impact to the medical device industry. Regulatory and quality professionals are still learning some of the nuances, and with the ...
As artificial intelligence (AI) and machine learning (ML) continue to transform healthcare, regulatory professionals must navigate increasingly complex and rapidly evolving global requirements. This ...
Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during fiscal year (FY) 2024, according to a report from the US Food and Drug ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Study: Patient, consumer reps at FDA adcomms increasingly hold ties to pharma-backed advocacy groups
At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to ...
Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
SGS is excited to bring to the GTA a comprehensive full-day symposium focused on the medical device industry. In partnership with the RAPS Ontario Chapter, the leading association for regulatory ...
The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet ...
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