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Date Posted
News Title
2024/03/25
Asia: Malaysia NPRA Update Guideline for Facilitated Registration Pathway (FRP)
2024/03/22
US: FDA offers guidance on observational studies as RWE
2024/03/21
Europe: EU patient groups say proposed definition of ‘unmet medical need’ is too restrictive
2024/03/20
AI: Experts discuss regulatory approaches for AI and current industry practices
2024/03/19
US: EPA announces final rule to slash toxic emissions of ethylene oxide and reduce cancer risk
2024/03/18
Australia: TGA consults on updated draft companion diagnostics guidance
2024/03/15
Europe: MHRA response to Equity in Medical Devices: Independent Review
2024/03/14
Europe: European Commission proposes new measures for the better lifecycle management of medicine authorisations
2024/03/13
US: Experts discuss how to avoid STeP, breakthrough device submission missteps
2024/03/12
Europe: European Commission proposes framework for joint clinical assessments
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