Simpler Grants.gov #FOR-FD-24-003

FDA Seeks AI/ML Model for Post-Market Surveillance of Complex Generic Drugs

The Food and Drug Administration (FDA) is seeking applications for a cooperative agreement to develop and test an artificial intelligence (AI) or machine learning (ML) algorithmic model using real-world data (RWD) for post-market surveillance of complex generic drug products. - Government Buyer: - Food and Drug Administration (FDA) - OEMs and Vendors: - No specific OEMs or vendors are named; this is a research grant opportunity open to eligible organizations - Products/Services Requested: - Development and testing of an AI/ML-based algorithmic model - Model must use real-world data to compare clinical outcomes between complex generic drugs and their reference listed drug (RLD) counterparts - Focus on post-market surveillance, therapeutic equivalence, and regulatory decision support - Unique or Notable Requirements: - Use of AI/ML and real-world data to automate and modernize post-market surveillance processes - Broad eligibility: nonprofits, government, business, and educational organizations may apply - Single cooperative agreement award, expected value $300,000

Description

This funding opportunity from the Food and Drug Administration aims to develop and test an AI- or ML-based algorithmic real-world data model for post-market surveillance of complex generic drug products. The goal is to compare clinical outcomes between complex generic products and their reference listed drug counterparts to monitor therapeutic equivalence and inform regulatory decisions. Eligible applicants include a wide range of nonprofit, government, business, and educational organizations. The award is a cooperative agreement with an expected single award of $300,000.

View original listing