Intelligent Bio Solutions' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Intelligent Bio Solutions (INBS).
Over the past two years, Intelligent Bio Solutions has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SMARTOX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SMARTOX FDA Regulatory Events
SMARTOX is a drug developed by Intelligent Bio Solutions for the following indication: in drug and alcohol screening services.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SMARTOX
- Announced Date:
- July 15, 2025
- Indication:
- in drug and alcohol screening services
Announcement
Intelligent Bio Solutions Inc announced a new global distribution agreement with SMARTOX®, a Texas-based leader in drug and alcohol screening services, to bring its SmarTest Patch drug detection product to international markets outside of the United States ("U.S") and Canada.
AI Summary
Intelligent Bio Solutions Inc. has signed a global distribution agreement with Texas-based SMARTOX® to bring its groundbreaking SmarTest® Patch drug detection product to international markets outside the United States and Canada. The SmarTest Patch is a wearable, non-invasive device that continuously tests for a broad range of substances through sweat over a period of 7 to 10 days. This innovative solution is discreet, water-resistant, and tamper-evident, making it an ideal choice for environments that require extended drug monitoring, such as justice and rehabilitation settings.
This new partnership allows Intelligent Bio Solutions to expand its portfolio and offer more flexible testing options, meeting diverse customer needs with enhanced accuracy and ease of use. The move reinforces the company’s commitment to providing rapid, non-invasive drug testing solutions on a global scale.
Read Announcement
Intelligent Bio Solutions FDA Events - Frequently Asked Questions
As of now, Intelligent Bio Solutions (INBS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Intelligent Bio Solutions (INBS) has reported FDA regulatory activity for SMARTOX.
The most recent FDA-related event for Intelligent Bio Solutions occurred on July 15, 2025, involving SMARTOX. The update was categorized as "Provided Update," with the company reporting: "Intelligent Bio Solutions Inc announced a new global distribution agreement with SMARTOX®, a Texas-based leader in drug and alcohol screening services, to bring its SmarTest Patch drug detection product to international markets outside of the United States ("U.S") and Canada."
Currently, Intelligent Bio Solutions has one therapy (SMARTOX) targeting the following condition: in drug and alcohol screening services.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:INBS) was last updated on 7/19/2025 by MarketBeat.com Staff
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