Sentinel System Task Order to address an Emerging Safety Need
This AI project is designed to solve the problem of efficiently validating emerging safety signals through chart review when traditional structured data is insufficient. It aims t…
AI for Regulatory Review (AIRR) Pilot
The AI-assisted regulatory review paradigm addresses the inefficiency and administrative burden of manually searching through vast amounts of disconnected sponsor-submitted and FD…
AI-assisted Platform for Clinical Pharmacology Review
The AI solution addresses inefficiency in the clinical pharmacology review process by reducing time reviewers spend on routine tasks, allowing them to focus their expertise on com…
AI for Bioanalytical Study Risk Assessment and Inspection Readiness
Challenges in assessing large amounts of analytical/bioanalytical study information for risk assessment and inspection preparation in a short period of time
AI for Clinical Study Risk Assessment and Inspection Preparation
Challenges in assessing large amounts of clinical study information for risk assessment and inspection planning in a short period of time
AI for Assessing Bioanalytical Study Conduct Alignment with Guidance and Method SOPs
Cross-comparing large amounts of bioanalytical data (reports, validation, tabulated data) with the M10 guidance and aligned method Standard Operating Procedures (SOPs) to identify…
Renamed: Document Room Submission AI-Assisted Categorization Previously: Document Room Submission Auto-categorization
Current document room submission categorization process is very manual and costly, impacting end-to-end regulatory review acceleration by creating bottlenecks, increasing processi…
Renamed: AI-Assisted Drug Review Letter Drafting Previously: Drug Review Letter Generation using GenAI
This approach to AI-assisted document drafting provides faster implementation with minimal technical requirements, future-proofs document generation capabilities, reduces ongoing…
Medical Data Enterprise Artificial Intelligence (MDE AI)
Create efficiencies in the regulatory review processes for medical devices; reduce administrative burden to staff and allow them to focus their expertise on scientific and clinica…
Food AI Decision Engine (FAIDE)
Prioritize limited regulatory resources and maximize public health protection.
Warp Intelligent Learning Engine (WILEE)
Identify emerging chemical signals and violative food substances by analyzing a large data set in a fraction of the time that it would have taken scientific reviewers to analyze t…
Rapid Intuitive Pathogen Surveillance (RIPS)
Identify and prioritize incoming sources of potential foodborne outbreaks, maximizing public health by reducing the time burden on regulators.
AI-Powered Assistant for Pathogen Detection (AIPD)
The AIPD is designed to address several key challenges in data analysis for foodborne pathogens, such as accessibility barriers for data sources, manual workflow overhead, knowled…
Product Label and Text Extraction System (PLATES)
Manual food label data extraction causes slow data accessibility and insights. Manual data processing and standardization causes slow data accessibility and insights. Decentrali…
Data Ingestion and Content Explorer (DICE)
Multiple stakeholders across HFP have the business need to search for content within artifacts and documents uploaded to various systems. For systems like CARA and CARTS, document…
ChatBot for Safety Reporting Portal Adverse Events and Product problems submissions
Increases data integrity and aid with routing the user to the correct commodity group to submit their adverse event or product problem. DRUID AI, a COTS tool, boasts a comprehensi…
Machine Learning as a Service: Translate and extract text from images using AI
This AI project is designed to solve the problem of reviewing foreign products, extracting ingredient lists, and border inspections
Machine Learning as a Service: Extract data from product labels, business forms, and image files
This AI project is designed to assist in capturing data submitted to & reviewed by the FDA by extracting text and data, determining its structure, and saving the information in a…
Intelligent Document Processing to analyze current import entry documentation for potential discrepancies
The intent is to assist in the process of discrepancy identification between documentation submitted by trade and CBP line data submitted.
HRSA Data Warehouse ChatBot
HRSA Data Warehouse Chatbot to respond to public Inquiries.
Targeted Technical Assistance
AI will help identify the health centers/ geographic areas that will benefit the most from targeted technical assistance on clinical topics for improving quality metrics
Image generator for presentation support
There are often scenes of field work that are difficult to photograph for use in educational presentation. AI has been used to generate images that approximate those field operati…
Volpara Imaging Software
Generates volumetric measurements of breast x-ray scans.
PINGOO.AI
Enhanced patient health literacy through education and patient engagement.