ACNU PLATFORM & REGULATORY GUIDANCE.
EMPOWERING CONSUMERS WITH DIRECTED SELF-CARE.
Think of the future – a future where consumers don't wait for a prescription to manage their health. That's the reality we're engineering. Our dedication to healthcare accessibility has led us to forefront of self-selection technology, enabling greater access to healthcare. We're not simply participating in the changing healthcare paradigm – we're building it, putting the power of directed self-care right into the hands of consumers.
DRUG DISCOVERY TO MARKET LAUNCH.
CodeScripts simplifies ACNU and tech-assisted drug approvals for pharmaceutical companies. It assesses ACNU feasibility, explores market opportunities with real-world data and AI/ML/DS models, and organizes key data into a streamlined dashboard, easing safety assessments, payment, and fulfillment from clinical trials to FDA feedback.
AI DRIVEN PROTECTION.
We're committed to maintaining a secure platform, integrating cloud native security for reliable protection, and combining continuous vulnerability scanning, third-party testing, and AI-driven monitoring. Our focus on updating security features, alongside routine risk assessments and process audits, ensures robust defense against cyber threats.
WE HANDLE SaMD SO YOU CAN FOCUS ON CARE.
With regulatory compliance built-in, CodeScripts greatly reduces both time to market and risk. You benefit from proven, scalable technology, backed by ongoing support and updates, ensuring that your medical device software remains at the forefront without the hefty costs and extended timelines of starting from scratch. CodeScripts lets you focus on innovation and patient care, rather than the complexities of SaMD development.
ACNU
SaMD PLATFORM
ACNU PLATFORM
CODESCRIPTS
An ACNU, or Additional Condition for Nonprescription Use, is an FDA rule to expand nonprescription drugs. It permits prescription drugs to switch nonprescription if conditions ensure safe use without a provider. These conditions, like apps or questionnaires, guide self-selection and usage, enhancing OTC drug safety.
The FDA's ACNU proposal aims to widen medication access through a tech-assisted pathway, addressing drug labeling limitations and fewer approved switches. This aligns with the shift in US healthcare to chronic condition management and self-care, adapting to fewer doctor visits and more virtual healthcare settings.
ACNU:
BRIGHT HORIZONS FOR SELF-CARE.
Algorithm
Decisions are made via an embedded qualification algorithm.
Prompts users for precise health information and makes informed decisions that are consistent with physician assessments.
Consumers with lower literacy levels have a higher degree of safety via self-selection.
Labeling
Decisions are made by consumers based on the information in DFL and on the principal display panel of product’s container.
For certain drug products, limitations of labeling present challenges for adequate communication of information.
Drugs Facts Labeling vs ACNU Algorithm
LABELING
Decisions are made by consumers based on the information in DFL and on the principal display panel of product’s container.
For certain drug products, limitations of labeling present challenges for adequate communication of information.
ALGORITHM
Decisions are made via an embedded qualification algorithm.
Prompts users for precise health information and makes informed decisions that are consistent with physician assessments.
Consumers with lower literacy levels have a higher degree of safety via self-selection.
TACTiC TRIAL '24 TECH-ASSISTED CHOLESTEROL TRIAL IN CONSUMERS
ACNU CLINICAL STUDY: In the Technology-Assisted Cholesterol Trial in Consumers (TACTiC) sponsored by AstraZeneca, our device successfully demonstrated that participants could safely and effectively select, acquire, and use rosuvastatin calcium 5-mg over a six-month period, suggesting that technology-assisted self-management of statins is feasible.
