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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
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USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...

Sharan Murugan
Jan 7, 20252 min read
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USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...

Sharan Murugan
Apr 5, 20231 min read
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Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e;...

Sharan Murugan
Nov 27, 20222 min read
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