Major pharmaceutical companies are urging the US Food and Drug Administration (FDA) to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems (CCS) for drugs ...
Top US Food and Drug Administration (FDA) medical device officials said they are focused on restaffing after last year’s reduction-in-force (RIF) and are optimistic about the Medical Device User Fee ...
Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and ...
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 ...
The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet ...
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 ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring ...
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