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Former FDA Reviewer Explains ‘Factoring’ For Human Factors At RAPS

Former FDA Reviewer Explains ‘Factoring’ For Human Factors At RAPS

 
• By Elizabeth Orr

At RAPS Convergence in Montreal, former FDA reviewer Rita Lin discussed the ways the agency wants to see developers consider human factors.

FDA 2024: Watch For Trial-Diversity Guidance, Final Quality Systems Rewrite

FDA 2024: Watch For Trial-Diversity Guidance, Final Quality Systems Rewrite

 
• By Elizabeth Orr

Industry observers at RAPS Convergence in Montreal last week said the FDA’s agenda for 2024 is likely to include increased emphasis on MDUFA goals, enhanced cybersecurity requirements, the new QMSR, and more. 

FDA Gives Insight On Changing Approval Landscape

FDA Gives Insight On Changing Approval Landscape

 
• By Elizabeth Orr

Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.