AI-Powered Regulatory Intelligence

Regulatory Intelligence Without Limits

Real-time FDA tracking, CRL analysis, and competitive intelligence — unified in one comprehensive platform.

45s
Avg Search Time
10+
Data Sources
90%
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Leaf Intelligence
Leaf Intelligence
AI Research Platform

Search for a compound / condition

Timeline: 7 years back 2018–2025
2010 2011 2015 2018 2025

Enter a drug name and click "Search" to analyze clinical trials

Example: Ketamine, Psilocybin, Esketamine, PCN-101, COMP360

Competitor Update
Label Change Detected

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platform overview

Source Coverage

Data Sources we aggregate

A simple overview of the public datasets Leaf Intelligence pulls from—no clicking around required.

ClinicalTrials.gov

  • •Trial phase
  • •Endpoints
  • •Enrollment status
  • •Trial design

FDA Data

  • •Complete Response Letters
  • •Warning Letters (NDAs)
  • •Adverse Events (FAERS)
  • •483's
  • •Summary Basis of Approval

EMA Data

  • •Medicines & Orphan Designations
  • •PIP & PSUSA
  • •Shortages & Safety
  • •Herbal Medicines

Orange Book

  • •Patent & Exclusivity Data
  • •Generic Equivalence
  • •Approval Routes
  • •RLD Status

DailyMed

  • •Product Labeling
  • •Boxed Warnings
  • •Dosage & Administration
  • •Drug Interactions

PubMed

  • •Peer-Reviewed Studies
  • •Trial Outcomes
  • •Safety Findings
  • •Meta-Analyses

All sources are automatically ingested and traceable in exports for auditability.

Comprehensive, Verifiable Sources

We aggregate public sources with validation methods documented in exports

Trial Analysis

Drug: albuterol • 212 trials analyzed
Total Enrolled
460,235
Average per Trial
2,301
Median Size
70
Size Range
1 - 12,417

Trial Size Distribution

81
Very Small
< 50
47
Small
50-100
46
Medium
100-500
8
Large
500-1K
12
Very Large
1K-5K
6
Mega Trial
> 5K

Age Demographics

Average Min Age 17 years
Average Max Age 52 years
Age Group Distribution
Children (<18)
41 (29%)
Adults (18-65)
102 (71%)
Mixed Ages
68 (48%)

Gender & Special Populations

Gender Distribution
Male Only
2 (1%)
Female Only
2 (1%)
All Genders
208 (98%)
Special Populations
73
Pediatric
112
Geriatric
73
Renal
69
Hepatic

Orange Book Information

165 Products | 45 Patents | 1 Exclusivity | Page 1 of 4

Orange Book Overview

165
Products
45
Patents
1
Exclusivity
43
Applications
5
Orphan Patents

Products (Sorted by Importance)

AIRSUPRA
Patents: 1 Exclusivity: 1
Form: AEROSOL, METERED;INHALATION
Strength: EQ 0.09MG BASE/INH;0.08MG/INH
Application: N 214070
Product #: 001
ANDA
PROAIR HFA
Patents: 9
Form: AEROSOL, METERED;INHALATION
Strength: EQ 0.09MG BASE/INH
Application: N 021457
Product #: 001
ANDA
PROAIR DIGIHALER
Patents: 21
Form: POWDER, METERED;INHALATION
Strength: EQ 0.09MG BASE/INH
Application: N 205636
Product #: 002
ANDA
PROAIR RESPICLICK
Patents: 9
Form: POWDER, METERED;INHALATION
Strength: EQ 0.09MG BASE/INH
Application: N 205636
Product #: 001
ANDA

Drug Labeling Information

71
APPLICATIONS
89
COMPANIES
106
LABEL VERSIONS
331
CHANGES
LATEST UPDATE
Sep 4, 2025

⚖️ Label Comparison

Label 1
1c50cca5-7c4d-d3de-e0b3-0394a90aebb6
Label 2
1c72fd84-7dbc-4500-db88-fb4221ce369f
Pharmaceutical Product

These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA.

VENTOLIN HFA (albuterol sulfate inhalation aerosol), for oral inhalation use

Pharmaceutical Product

ALBUTEROL SULFATE Inhalation Aerosol, with Dose Indicator FOR ORAL INHALATION ONLY Prescribing Information

👥 PubMed Comprehensive Drug Analysis

Advanced multi-dimensional analysis covering pivotal trials, approval pathways, RWE, and more

5 Analysis Categories
AI-Powered Insights
🧪

Pivotal Trials

Registration studies & regulatory endpoints

✅

Approval Pathways

FDA designations & regulatory strategies

📊

Real-World Evidence

Post-market studies & registry data

💡

Recovery Strategies

Failed trial recovery & post-hoc analyses

14789 articles found (showing page 1 of 2)
Levalbuterol versus albuterol.
Ameredes BT, Calhoun WJ
Curr Allergy Asthma Rep • Sep 1, 2009 • PMID: 19671384
Design: Superiority, Treatment: Albuterol, Corticosteroid, Condition: Asthma, Finding:

With inhalation of racemic albuterol, circulating (S)-albuterol persists 12 times longer than levalbuterol, suggesting potential for paradoxical effects observed clinically. Although mainly consistent with basic findings, clinical studies suggest no overwhelming superiority of levalbuterol over racemic albuterol; however, levalbuterol's effects may be greatest in moderate to severe asthma patients, especially with racemic albuterol overuse.

Albuterol has been used for more than 40 years to treat acute asthma exacerbations as a racemic mixture of isomers...

asthma albuterol corticosteroid cost

FDA Documents

Drug Applications

NDAs: Branded ANDAs: Generics
KETALAR
NDA016812 BRANDED
Manufacturer: Par Health USA, LLC
Approved: Apr 4, 1980
✓ docs found
Products on NDA016812 (3 dosage forms)
DRUG NAME ACTIVE INGREDIENTS STRENGTH DOSAGE FORM/ROUTE MARKETING STATUS TE CODE
KETALAR KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML INJECTABLE; INJECTION Prescription None
KETALAR KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE; INJECTION Prescription None
KETALAR KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML INJECTABLE; INJECTION Prescription None
📁 FDA Documents (1 found)
Other (1): 📄 drugs-at-fda-link
KETAMINE HCL
ANDA071949 GENERIC DISCONTINUED
Manufacturer: QUAD PHARMS
Approved: Discontinued
No docs (discontinued)
Products on ANDA071949 (1 dosage form)
DRUG NAME ACTIVE INGREDIENTS STRENGTH DOSAGE FORM/ROUTE MARKETING STATUS TE CODE
KETAMINE HCL KETAMINE HYDROCHLORIDE KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML Injectable; Injection Discontinued None
EMA

European Medicines Agency Information

Regulatory data across 11 specialized collections

Database Status:
Active
Coverage: EU/EEA Medicines • Source: EMA Official Database
💊 Drug:
📍 Condition: Not specified
⏱️ Timeline: 2 years back

Found 7 EMA records for "Lisinopril"

Renin-angiotensin-system (RAS)-acting agents

INN:

captopril,imidapril,zofenopril

Status: European Commission final decision
Reference: EMEA/H/A-31/1370

Lisonorm

INN: lisinopril,amlodipine
Status: European Commission final decision
Reference: CHMP/633842/2008

Compliance & Manufacturing Intelligence

FEI tracking, inspection history, warning letters, and regulatory actions

29
Total Manufacturers
15
With FEI Numbers
40
Total FEI Numbers
14
Without FEI

Manufacturers with FEI Numbers

MANUFACTURER FEI COUNT PRODUCTS CLASSIFICATIONS CITATIONS ACTIONS REFUSALS ACTIONS
Henry Schein, Inc. 7 2 1 0 0 12
Henry Schein, Inc 7 1 1 0 0 12
Fagron Inc 5 1 2 0 0 9
Hospira, Inc. 4 4 70 69 3 17
PCAS 4 1 12 0 0 9
Hikma Pharmaceuticals USA Inc. 3 3 43 18 3 17
Supriya Lifescience Limited 2 2 3 0 0 6
Active FEI
Classifications
Citations
Regulatory Actions
Import Refusals

Why Teams Choose Leaf Intelligence

Immediate insights that reduce risk, accelerate compliance, and keep you ahead of competitors.

Comprehensive data platform

We pull from over 10 plus sources to provide a complete view of regulatory landscapes. Including Pubmed and FDA databases.

Faster Response

Instant precedent evidence to support submissions and audits. Instead of research timelines stretching into weeks, get answers in minutes.

Intuitive Ui

No need for complex governance sites Our user-friendly interface simplifies compliance management.

Hallucination Proof

We link back every insight to its original source, ensuring transparency and trust.

How Leaf Intelligence Works

From raw FDA and EMA data to strategic intelligence—clear, verifiable, actionable.

1

Ingest

FDA/EMA, ClinicalTrials.gov, Orange Book, PubMed.

2

Normalize

Entity resolution, deduplication, quality assurance.

3

Analyze

AI detects risks, anomalies, and competitive signals.

4

Deliver

Dashboards, alerts, and exportable reports for teams.

Tailored for Your Role

Every team member gets insights and workflows aligned with their priorities.

Regulatory Affairs

Defend strategy with evidence, respond faster, and stay audit-ready.

Spot CRL Risks Early

Benchmark FDA precedent to anticipate and pre-empt potential roadblocks.

Portfolio Labeling Monitor

Track competitor label shifts to defend your positioning.

Evidence-Based Responses

Auto-surface precedent examples to strengthen CRL reply packages.

Comprehensive, All-In-One solution

Find relationships between datasources and streamline your workflows.

Try our Tool now

Clinical / Medical

Optimize trial design, endpoints, and reduce burden with precedent insight.

Trial Endpoint Library

Search and benchmark accepted endpoints across conditions.

Recruitment Insights

Spot trial designs that minimized recruitment delays.

Comparator Strategies

See which comparators FDA accepted across therapeutic areas.

Safety and Adverse Events

Review safety signals by drug or condition.

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R&D

Accelerate discovery with precedent-aware research and automated evidence reviews.

Approval Package Explorer

Navigate FDA/EMA approval packages across clinical, CMC, and labeling components.

PubMed AI Analysis

Summarize thousands of abstracts; cluster by endpoints, MOA, and safety signals.

Historical Trials Intelligence

Compare historical designs, arms, and outcomes to surface proven precedents.

Review Packages & SBOA

Generate concise summaries from review docs and Summary Basis of Approval.

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Business / BD

Inform strategy with integrated commercial, reimbursement, and compliance signals.

Custom Commercial Data

Blend claims, sales, KOL, payer policy, or internal sources for unified insight.

Reimbursement & Code Analytics

Track CPT/HCPCS/DRG changes, coverage policies, and access trends.

Spending & Market Signals

Analyze HCP/HCO spend, grants, tenders, and utilization patterns.

Compliance & Letters

Monitor warning letters, 483s, and enforcement actions to de-risk plans.

Explore Integrations

Frequently Asked Questions

How do you validate data?

We cross-check against primary sources and maintain link-backs and changelogs for auditability.

What's the pricing model?

Tiered by users and data scope. Contact us for a customized quote based on your needs.

Ready to Transform Your Regulatory Operations?

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10+
Data Sources
45s
Avg Search Time
90%
Cut research time