AI to Improve Public Access to the Administrative Appeals Process
More effectively leverage online resources to better assist the public and reduce the number of misfiled appeals submitted to the Departmental Appeals Board (DAB) via electronic f…
AI Use Policy Tool
Ensure public confidence in the integrity of DAB decisions by maximizing quality review standards and reducing errors.
Resources to Assist the Advisory Board In Identifying AI Tools for Use In An Adjudication Environment
Agency adjudication activities require the analysis of large quantities of data to conduct docket analysis, identify efficiencies in case processing, and conduct 508 compliance re…
Renamed: 356H Machine Learning (ML) Facility Supply Chain Role Classification Previously: 356H ML Facility Supply Chain Role Classification
Manual classification of facility supply chain roles from FDA industry submissions (356h forms) is time-consuming and inefficient
Renamed: Risk-based FAR Review & Decision Support Previously: Field Alert Reports (FAR) Prioritization Model
Manual and subjective assessment process for Field Alert Reports (FARs) can lead to inconsistency in prioritizing and assessing reports, potentially leading to ineffective resourc…
Analytics-Driven Supplement Evaluation (ASE)
Exponential increase in post-approval chemistry, manufacturing, and controls (CMC) change submissions, with 80% being Changes Being Effected (CBE-30/0) notifications that may be s…
Renamed: FAR-based Facility Signal Detection Tool Previously: Post-market Surveillance Reports Signal Detection and Cluster Analysis.
Need for proactive detection of quality signals in post-market surveillance reports using statistical process control and topic modeling to identify potential drug quality hazards…
MedWatch Dashboard
Need to proactively identify emerging issues and clusters within MedWatch reports using advanced analytics.
Quality Surveillance Dashboard (QSD)
Need for consistent, data-driven assessment of drug manufacturing facilities and proactive detection of potential quality signals that could indicate problems with drug safety or…
Annual Report CMC
FDA receives numerous annual reports from drug manufacturers containing important manufacturing and quality information, but key details can be difficult to locate quickly within…
Renamed: Application References Previously: Application-DMF Reference
FDA receives extensive drug application submissions that contain valuable references to related applications, but these relationships aren't always captured in existing regulatory…
Renamed: Extracting DMF Facilities from unstructured documents Previously: DMF (Drug Master File) Facilities
FDA receives Drug Master File (DMF) submissions containing valuable information about manufacturing facilities, but this data exists in various document formats that require manua…
Renamed: Information Visualization Platform (InfoViP) to Support Analysis of FAERS safety reports Previously: Information Visualization Platform (InfoViP) to Support Analysis of adverse event reports
The AI is intended to support the analysis of FAERS Individual Case Study Reports in post-market safety surveillance by automating duplicate detection, creating temporal visualiza…
LLM-Assisted VAERS Analyses
Extraction of relevant information, tabulation of data, find patterns across adverse events reports, and generate hypotheses for further investigations.
Renamed: Module 3 Facilities Extraction Previously: Module 3 Faculties
FDA receives drug application submissions (ANDA, NDA, BLA) that contain important manufacturing facility information in Module 3 documents, but this data requires manual review to…
Packaging Materials and Suppliers
FDA needs to efficiently identify which Drug Master Files (DMFs) contain specific packaging materials and understand how these materials connect to drug applications, but this inf…
Process Large Amount of Submitted Docket Comments
Deduplication of public comments, and generating draft sentiment analysis and grouping of comments
Real World Data/Evidence
FDA receives numerous submissions containing real-world data and evidence, but identifying and cataloging these studies across various submission types is time-intensive and criti…
Regulatory Starting Material
FDA needs comprehensive visibility into the upstream supply chain for drug manufacturing, particularly tracking regulatory starting materials and their suppliers across approved a…
Resource Capacity Planning
FDA needs to accurately predict the volume and complexity of incoming drug application submissions to ensure appropriate staffing and resources are available for timely reviews un…
Supply Chain Resilience Program, Office of Supply Chain Resilience (OSCR) - Foresight
Estimating potential future demand of medical devices
HIVE AI Pilot
The AI is intended to assist in solving several problems related to the review process for INDs. Specifically, it aims to address issues of inefficiency, delays in identifying de…
AI and Vaccine Labeling
The app is designed to streamline vaccine label review processes, offering several key features to simplify and improve efficiency. It includes MedDRA integration for term searche…
CDER Publications
Inefficient manual curation and categorization of publications by CDER authors. It aims to automate the process of organizing publications by focus areas for data call responses a…