In the TACTiC trial 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.
Study Record
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
TACTiC Trial
Technology & FDA Regulatory Guidance for ACNU and Digital Health Solutions.
Restart switches that failed due to self-selection /
Revitalize mature brands to extend lifecycles /
Overcome drug labeling limitations /
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.
VS
Algorithm
Technology-Assisted Self-Selection
ACNU
ADDITIONAL CONDITION FOR NONPRESCRIPTION USE
WHAT IS AN ACNU?
An ACNU, or Additional Condition for Nonprescription Use, is a proposed rule introduced by the FDA to broaden the range of nonprescription drugs.
This rule allows qualified prescription drugs to switch to nonprescription if additional conditions are met to ensure their safe and effective use without a healthcare provider's supervision.
"Additional Condition" refers to specific requirements set by the FDA that ensure consumers can safely and effectively use a nonprescription drug.
These conditions might involve tools like apps or questionnaires to guide self-selection and usage, enhancing drug safety for OTC purchases.
WHY IS THE FDA PROPOSING ACNU?
The FDA's proposal of ACNU is driven by a multifaceted approach to public health improvement, aiming to widen medication access for more people.
By introducing a tech-assisted pathway, it tackles the dual challenges of current drug labeling limitations and the decrease in approved drug switches.
This move aligns with the broader shift in US healthcare from acute care to focusing more on chronic condition management and self-care.
Additionally, it addresses the changing landscape of patient care, characterized by a decrease in regular doctor visits and an uptick in virtual healthcare settings, ensuring medications are more accessible in the evolving healthcare paradigm.
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CodeScripts - ACNU Platform
How The Platform Works /
CodeScripts is a SaMD digital care platform designed for pharmaceutical companies, simplifying the process of securing ACNU and technology-assisted drug approvals. It enables you to assess ACNU feasibility and explore market opportunities using real-world data and AI/ML/DS models.
The platform organizes key data—from clinical trials to FDA feedback—into a streamlined dashboard, easing processes across safety assessments, payment, and fulfillment. With its robust data and analytics capabilities, CodeScripts efficiently guides your development journey from concept to market readiness.
Security & Risk Monitoring /
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.
Why CodeScripts Over Custom SaMD /
CodeScripts offers notable advantages over custom SaMD. With regulatory compliance built-in, it 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.