The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and ...
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 ...
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 ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
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 ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring ...
Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
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