Create an adaptive risk model annex document for AI-driven drug discovery projects addressing evolving FDA guidance on machine learning in pharmaceutical development

Generate create an adaptive risk model annex document for ai-driven drug discovery projects addressing evolving fda guidance on machine learning in pharmaceutical development for Scientific Research and Development Services industry

Scientific Research and Development Services

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Current FDA Draft Guidance Reference *

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Allowed: PDF, DOCX, TXT

Max size: 50MB

Upload the latest FDA guidance documents (draft or final) on AI/ML in drug development, including relevant Federal Register notices and public comments

AI Model Development Phase *

Specify the current development stage to address appropriate regulatory expectations

Primary Regulatory Stakeholders *

Identify the FDA division(s) that will primarily review this AI application

AI Model Risk Classification *

Categorize the risk level based on AI model impact on patient safety and decision-making

Data Sources Used *

List the primary data sources and databases utilized for model training and validation

Regulatory Submission Type *

Specify the anticipated submission pathway requiring AI model documentation

Algorithm Transparency Requirements *

Define the level of explainability required by FDA based on model complexity

Quality Management System Standards *

Indicate relevant quality standards governing AI development in your organization

Model Validation Strategy *

Define the specific validation approaches and statistical methods for regulatory acceptance

Precedent AI Applications

Reference FDA-approved AI applications similar to your use case for regulatory precedent

Regulatory Timeline *

Indicate the timeline flexibility for FDA review and feedback cycles

Create an adaptive risk model annex document for AI-driven drug discovery projects addressing evolving FDA guidance on machine learning in pharmaceutical development

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