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USA – AI in drug development: FDA draft guidance addresses product lifecycle, risk

Year: 2025

Type: other

Abstract: The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or information that supports regulatory decision-making in submissions for drugs and biological products. In the draft guidance, FDA proposes using a risk-based credibility assessment framework for AI use in product submissions based on context of use (COU). The framework would apply when AI produces information or data that would lead to a regulatory deci...

Source: Industrias Culturais (Universidade de Coimbra)

DOI: 10.58079/1391a

Author: Vroby

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W6955634017

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