Search
USFDA Guidance: Use of Artificial Intelligence To Support Regulatory Decision & Guiding Principles of Good AI Practice in Drug Development
Artificial Intelligence (AI) is no longer a future concept in pharmaceutical research—it is already influencing how drugs and biological products are discovered, developed, manufactured, and monitored throughout their lifecycle. However, when AI outputs are used to support regulatory decisions , questions of trust, transparency, and accountability become critical. Recognising this, global regulators have begun defining expectations for the responsible use of AI in drug devel
Sharan Murugan
Jan 313 min read
IMDRF Med Dev Guidance: Good Machine Learning Practice (GMLP) for Medical Device Development: IMDRF’s Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has released its final guidance document (IMDRF/AIML WG/N88:2025) outlining...
Sharan Murugan
Feb 1, 20253 min read
IMDRF Guidance: Good Machine Learning Practice for Medical Device Development: Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...
Sharan Murugan
Jul 3, 20242 min read