                                                            
          ··········                    ··········          
        ··◎◉⊙⊚⊛◠◡○●··                 ··◠◡○●◌◎◉⊙⊚··         
     ··○●◌◎◉⊙⊚⊛◠◡○●◌◎··            ··⊙⊚⊛◠◡○●◌◎◉⊙⊚⊛◠··       
    ·◠◡○●···· ····●◌◎◉·          ··◎◉⊙⊚···· ····⊚⊛◠◡··      
  ·⊚⊛◠··    │     ··◎◉⊙·        ·●◌◎··    │     ··◠◡○·      
·◉⊙⊚··│     │     │··◉⊙⊚·     ·◡○●··│     │     │··◡○●·     
◎◉·   │     │     │  ·⊙⊚⊛·  ·⊛◠◡·   │     │     │  ·○●◌·  ·◌
··    │     │     │  ··⊚⊛···⊚⊛·     │     │     │   ·●◌···●◌
│     │     │     │   ··⊛◠◉⊙··│     │     │     │   ··◌◎◡○··
│     │     │     │    ·◌◎◉·  │     │     │     │    ·◌◎◉·  
│     │     │     │  ··●◌◠◡·· │     │     │     │  ··⊚⊛◎◉·· 
│     │     │     │ ·◡○···◡○· │     │     │     │··◉⊙···◉⊙· 
│     │     │     ·⊛◠◡·  ·◡○●·│     │     │     ·◌◎◉·  ·◉⊙⊚·
··    │     │  ··⊙⊚⊛·     ·○●◌··    │     │  ··○●◌·     ·⊙⊚⊛
◠··   │     │··◎◉⊙·        ·●◌◎··   │     │··◠◡○·        ·⊚⊛
◠◡○···· ····○●◌◎·           ·◌◎◉⊙···· ····⊙⊚⊛◠·           ·⊛
◠◡○●◌◎◉⊙⊚⊛◠◡○●··            ··◎◉⊙⊚⊛◠◡○●◌◎◉⊙⊚··            ··
··○●◌◎◉⊙⊚⊛◠··                 ··⊙⊚⊛◠◡○●◌◎··                 
 ··········                    ··········

FDA Intelligence
Reimagined

Ask in natural language and watch the agent sweep FDA databases live. Then keep watching: risk-ranked portfolios, full-spectrum alerts across inspections, letters, recalls, and approvals, and share-ready Compliance Briefs — grounded in 117,000+ inspections and 125,000+ Form 483 observations.

Start Free Today

Regulatory Intelligence at Scale

Stop drowning in FDA databases. Start getting answers.

Live Agent Research

Watch the agent work in real time — every search step labeled as it runs, from planning through evidence checks. No black box, no dead air.

Portfolios

Paste your supplier list or competitor set and get a risk-ranked dashboard — recent OAIs, letters, and 483s sorted worst-first, with quarterly trend charts against industry averages.

Full-Spectrum Alerts

One watch covers a whole portfolio with live membership — and fires on inspections, warning letters, enforcement, recalls, and approvals. Compound signals flag when enforcement and market events converge on the same firm.

Compliance Briefs

One click turns any facility, company, or entire portfolio into a print-ready report — inspection history, CFR readiness scorecard vs peers, trend charts — with a shareable read-only link.

Peer Benchmarks & CFR Scorecards

A firm’s OAI and 483 rates against its product-type averages, and its citation themes against 125,000+ parsed observations — sample sizes always stated, elevated patterns flagged honestly.

Insights Canvas

Every claim wired to its evidence: linked tables, charts, and answer citations that jump to their source. Export to Excel, CSV, or JSON.

Deep Research

Multi-pass investigations that plan coverage, sweep every relevant database, close the gaps, and end with a structured report artifact you keep.

Drug, Device & Trial Data

Approvals, labels, recalls, shortages, FAERS and MAUDE adverse events, 510(k)s, PMAs, and ClinicalTrials.gov pipelines — one conversational interface, plus an MCP server for your own agents.

Ask Questions.
Get Answers.

No more digging through databases. Just ask what you need to know in plain English. Our AI understands regulatory context and delivers precise, sourced answers in seconds. Every answer is grounded in public FDA and government data — FDAgent does not provide medical advice.

"Is there a safety signal for Ozempic and pancreatitis?"

"Compare Pfizer and Moderna clinical trial pipelines"

"Show 510(k) clearances for cardiovascular devices in 2024"

"Find CDER warning letters mentioning data integrity"

██▓▓▓▒▒▒▒▒▒▓▓▓██▓▓▓▓▒▒▒▒▓▓▓▓▓▓▓▓
██▓▓▒▒▒▒▒▒▒▒▓▓██▓▓▓▓▒▒▒▒▓▓▓▓▓███
█▓▓▒▒▒░░░▒▒▒▓▓███▓▓▓▓▒▒▓▓▓▓▓████
▓▓▒▒░░░░░░▒▒▓▓▓██▓▓▓▓▓▓▓▓▓▓█████
▓▒▒░░░░░░░▒▒▒▓▓██▓▓▓▓▓▓▓▓▓▓████▓
▒▒▒░░░░░░░▒▒▒▓▓██▓▓▓▓▓▓▓▓▓████▓▓
▒▒░░░░░░░░▒▒▒▓███▓▓▓▓▓▓▓▓▓███▓▓▓
▒▒░░░░░░░░▒▒▓▓██▓▓▓▓▒▓▓▓▓▓██▓▓▓▓
▒▒░░░░░░░░▒▒▓▓██▓▓▓▒▒▒▓▓▓▓██▓▓▓▒
▒▒░░░░░░░▒▒▓▓██▓▓▓▒▒▒▒▓▓▓███▓▓▓▒
▒▒░░░░░░▒▒▒▓▓██▓▓▒▒▒▒▒▒▓▓███▓▓▒▒
▒▒▒░░░░▒▒▒▓▓██▓▓▓▒▒▒▒▒▒▓▓███▓▓▒▒
▒▒▒▒▒▒▒▒▒▓▓▓█▓▓▓▒▒▒▒▒▒▒▓▓▓██▓▓▒▒
▓▒▒▒▒▒▒▒▓▓▓██▓▓▒▒▒▒▒▒▒▒▒▓▓██▓▓▒▒
▓▓▓▒▒▒▓▓▓▓██▓▓▒▒▒░░░░▒▒▒▓▓██▓▓▒▒
▓▓▓▓▓▓▓▓███▓▓▒▒▒░░░░░▒▒▒▓▓██▓▓▒▒
██▓▓▓▓▓███▓▓▒▒▒░░░░░░░▒▒▓▓██▓▓▓▒
█████████▓▓▓▒▒░░░░░░░░▒▒▓▓██▓▓▓▒
▓██████▓▓▓▓▒▒░░░░░░░░░▒▒▓▓██▓▓▓▓
▓▓▓▓▓▓▓▓▓▓▒▒▒░░░░  ░░░▒▒▓▓███▓▓▓
▓▓▓▓▓▓▓▓▓▒▒▒░░░░   ░░░▒▒▓▓███▓▓▓
▒▒▓▓▓▓▓▒▒▒▒▒░░░░   ░░░▒▒▓▓███▓▓▓
▒▒▒▒▒▒▒▒▒▒▒░░░░░  ░░░░▒▒▓▓███▓▓▓
▒▒▒▒▒▒▒▒▒▒▒░░░░░░░░░░░▒▒▓▓███▓▓▓

117,000+

FDA Inspections

125,000+

Form 483 Observations

1,400+

Warning Letters, Full Text

12+

FDA Databases

Powered by Authoritative Sources

Real-time access to official FDA databases and ClinicalTrials.gov

openFDA

Drugs & Devices

FAERS

Adverse Events

MAUDE

Device Reports

ClinicalTrials.gov

Trial Data

510(k) Database

Clearances

PMA Database

Class III Approvals

Drug Labels

Package Inserts

NDC Directory

Drug Products

Recall Database

Safety Alerts

Warning Letters

Enforcement

  ························∙∘○◌◌○∘∙·····       ··∙∘∘∘
 ···················∙∙∘○○○◌●◉⊙⊙●◌∙·             ··∙∙
 ·······∙∘∘∘∘∙····∙∘○◌◌◌◌◌◎●◉⊚⊚⊙●○·               ··
 ····∙∘◌◎●●●◎◌○∙·∙∘○◌◌○∘∘∘∘○◌◎◉◉●◌∙·              ··
 ···∙○◎●●●●●●●◎◌○∘○◌◌○∘······∙○◎●◎○·              ··
 ··∙○◎●◎◌○∘○◌◎●◎◌◌◌◌◌○∙·······∙◌●◎○∙              ··
 ··∘◌◎●◌∘···∘◌◎◎◌◌○◌◌○∘∙∙·····∘◎●◎○·             ···
 ··∘◌◎●●◌○∘∘◌◎◎◌○∘∘∘○◌◌◌◌○∘∙∙∘◌●●◎∘·     ···    ····
··∙∘◌◎◉◉⊙◉◉◉◉●◎○∙···∘○◎●◉●●◎◌◌◎●◎○∙·    ·∙◌∙·    ···
∙∘∘∘○○◎●◉◉◉◉●◎○∙·  ··∘◌●◉⊙◉●◎◎◎◌○∙·      ···    ··· 
·∙∙∙∙··∙∙∘∘∘∘∘∙∙······∙○◎●●◎◌○○∘∙········     ····· 
 ·····      ···∙∙∙∙∙···∙∘∘∘∘∘∙∙∙··················· 
   ····       ··········∙∙∘∘∘∙········∙∙∙·········  
     ·····         ····∙∙∘∘○○∘∙··  ·····∙∙∙∙∙∙∙···  
     ······         ··∙∙∘∘○○○∘∘∙········∙∘○◌◎◎◌○∙···
     ······          ·∙∘∘∘∘∘∙∙∙∙∙∙∙··∙∙○◌◎●◉◉◉◉●◎◌◌○
·········          ···∙∙∘∘∙···∙∙∘∘○○◎●◉⊙⊙⊙⊙⊙⊙◉◉◉◉◉●●
···∙∙∙∙···········∙∙····∙∙·····∙∘○◎◉⊚⊚⊚⊚⊚⊙◉●◎◎◎◎◎◎◌◌
··∘○◎◎◎◌○∘∙····∙∙∙∙∙∙∙∙○◌◌◌◌○∘∘∘∘◌●⊙⊚⊚⊚⊙●◎◌◌○○○○○∘∙·
··○◎●◉●●●◌∘·······∙∘○○◌◎●◉◉◉●●◎◎◎●◉◉◉●◎○∘∘∘∘∙∙∙···· 
··○◎◎◎○◎◎◌∙·     ·∘○○○○○◌◌◎◌◌◌◎●⊙⊚⊚◉◎○∙············ 
··∘○◌◌◌◌◌∘·     ·∘○○∘∙········∙◌◉⊚⊚⊚●∘·········  ·· 
····∙∙∘∙··     ·∙○○∘·   ····· ·∙◎⊚⊚⊚◉○∙········   · 
··             ·∘○○∙    ····   ·○◉⊚⊚⊙◌∙·······      
··             ·∘○○·   ····    ·∘●⊚⊚⊚◎∘·······      
··             ·∘○○∙· ····     ·∘●⊚⊚⊚●○······       
··             ·∙○○○∘∙····     ·∘●⊙⊚⊙●◌∘∙···       ·
··              ·∘◌◎◎◌∘∙·    ·∙∘◌◎●●●◎◌◌○∘∙·······∙∘
··              ·∙○◎●●◎○∘∙·∙∙∘○◌◌◌○∘∙∘○◌◌◌○○∘∘∘∘∘○○○
····          ····∙∘○◌◌○○∘∘○○○○○∘∙·····∙∘∘∘∘∘∘∘○○○○∘

From question
to deliverable.

One thread runs the whole workflow: ask, watch the agent sweep the record live, inspect the evidence on canvas, open the facility behind any finding — and walk away with a brief your team can act on.

◉Every canvas result links to a full facility or company profile

◎Peer benchmarks put any firm against its product-type averages

●Compliance Briefs render print-ready, with a shareable read-only link

⊙Today in FDA and watch alerts keep the record coming to you

Example Queries

Just ask in natural language—no query syntax to learn

SafetyWhat are the most reported adverse events for GLP-1 agonists?

DevicesShow me Class I device recalls from the past 6 months

TrialsFind Phase 3 oncology trials recruiting in the US

ComplianceWhich companies received warning letters for 21 CFR Part 11 violations?

PipelineCompare Eli Lilly and Novo Nordisk diabetes pipelines

ApprovalsList all accelerated approvals for rare diseases in 2024

Business Intelligence

Identify Market
Catalysts.

Regulatory events create business opportunities. Warning letters trigger remediation projects. Pipeline shifts signal talent needs. Safety signals reshape competitive landscapes.

◉Warning letters that signal consulting opportunities

◎Pipeline expansions driving talent acquisition

●Regulatory setbacks creating competitive openings

⊙Approval milestones indicating commercialization hiring

Consulting

Find compliance challenges needing remediation

Recruiters

Track milestones driving hiring demand

Investors

Monitor catalysts affecting portfolios

Strategy

Analyze competitor setbacks in real-time

Ready to Transform Your
Regulatory Workflow?

Join hundreds of regulatory professionals who have already made the switch to AI-powered FDA intelligence.