Articles tagged with “ai-drug-development”

FDA ISTAND Program: AI Drug Development Tool Qualification

An educational guide to the FDA ISTAND program, explaining the DDT qualification process and the regulatory integration of AI-based drug development tools.

35 min read

7/2/2026

fda istand drug development tools ddt qualification regulatory science ai drug development clinical outcome assessment digital health technology

FDA AI Clinical Trial Pilot: Real-Time Oncology Monitoring

Examine the 2026 FDA real-time clinical trial pilot. This report analyzes how AI and cloud platforms enable continuous oncology data monitoring for new drugs.

30 min read

4/24/2026

fda clinical trials real-time monitoring ai drug development oncology trials clinical trial optimization regulatory affairs healthcare cloud analytics

FDA Draft Guidance on AI in Drug Development Explained

Examine the January 2025 FDA draft guidance on AI in drug development. This report details the 7-step credibility framework and excluded AI applications.

65 min read

4/1/2026

fda draft guidance ai drug development credibility framework context of use pharmaceutical regulation regulatory submissions fda ai policy

AstraZeneca's ChatGPT Strategy: An Enterprise AI Case Study

An in-depth case study of AstraZeneca's ChatGPT and generative AI implementation, updated for 2026. Covers enterprise strategy, R&D use cases, self-healing supply chains, and agentic AI adoption.

25 min read

10/10/2025

enterprise ai generative ai chatgpt enterprise ai in pharma llm implementation astrazeneca ai case study ai drug development ai