Why in news
The U.S. Food and Drug Administration (FDA) proposed draft guidelines on the use of artificial intelligence (AI) to assess the safety and effectiveness of drugs
AI has seen a sharp increase in drug-related submissions, with a 10-fold rise in AI-based drug development submissions in recent years.
Benefits and Use of AI
AI can improve drug development by analyzing human data, reducing animal testing, and predicting drug responses for vulnerable populations.
AI models can also predict unwanted side effects of drugs, making the process more efficient and human-relevant.
Challenges with AI in Drug Development
AI models depend on high-quality and unbiased data; poor data leads to inaccurate results.
Transparency and model reliability remain concerns, as AI's decision-making processes are often not fully open to scrutiny.
Global and National Adoption of AI Guidelines
Other regulatory bodies like the European Medicines Agency also have AI guidelines.
India's 2023 amendment allows AI-generated data in drug assessments, reducing reliance on animal trials.
These guidelines aim to standardize the drug approval process and improve safety measures globally.
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