Idea Evolver

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. #acnu #digitalhealth #otcswitch #publichealth

Danny Sullivan from Google recently offered clarification on talking points surrounding the recent core search algorithm leaks, namely the ones involving Navboost and user interactions: - User Interaction Data: Aggregated and anonymized; not the sole ranking factor. - Quality Content is Crucial: Focus on creating valuable content rather than just SEO tactics. - New Sites Can Rank: Fresh content can still achieve high rankings. - Diverse Traffic Sources: Aim for broader content promotion and varied traffic sources. Sullivan's statements are the latest entry to a tumultuous dialogue between the SEO community and Google's own search team in the wake of these leaks, which some believe to contain information that is contradictory to previous public statements from the search team. While there's plenty to potentially learn from these leaks, there's just as much that we can't draw definite conclusions from without further context. In these recent statements, Sullivan reiterates the basics that we know to be true regardless of any leaks - that the best way to bring in traffic is to produce unique, worthwhile content that speaks to the needs of your audience. Read more here: https://lnkd.in/ezq3vzFu

#clinicaltrials

Roy Perlis discusses the potential for over-the-counter (OTC) availability of selective serotonin reuptake inhibitors (SSRIs) to address the mental health crisis. Key points include: Proven Safety and Efficacy: SSRIs have been used safely and effectively for over three decades to treat depression and anxiety. Current Access Issues: Many people with depression struggle to access care due to limited availability of psychiatrists, long wait times, and logistical barriers. OTC Accessibility: Making SSRIs available OTC could increase access to treatment, providing a safe and effective option for those in need. Regulatory Considerations: To make this change, an SSRI manufacturer would need to demonstrate that consumers can understand and follow the medication label without clinician oversight. Perlis emphasizes that OTC SSRIs could help address the mental health crisis by offering a more accessible treatment option for depression and anxiety. #MentalHealth #PublicHealth #SSRI #HealthcareAccess #ACNU #SaMD #RxtoOTCSwitch

The study investigates how Real-World Data (RWD) and Real-World Evidence (RWE) are used in regulatory decisions for switching drugs from prescription-only (Rx) to over-the-counter (OTC) status by the EMA, FDA, MHRA, and BfArM. Key findings include: Data Sources and Acceptance: Regulatory jurisdictions with clear and transparent OTC policies and guidelines have more drugs available in the OTC segment. A variety of data sources, including RWD/RWE, support these switches, focusing on drug safety and consumer usage. Regulatory Frameworks: The study highlights the importance of clear and transparent regulatory frameworks for increasing OTC drug availability. It suggests that European Union regulators could benefit from benchmarking their switch frameworks against those of the UK and US. Challenges and Safety: The primary concern in Rx-to-OTC switches is drug safety, both intrinsic and related to consumer use. Successful switches often involve data demonstrating patient capability for self-diagnosis and appropriate drug usage. Economic and Public Health Impact: OTC availability can reduce healthcare costs and improve patient access to medications, supporting self-management of conditions. The study concludes that transparent regulatory processes and the use of RWD/RWE are crucial for facilitating future Rx-to-OTC switches, ultimately benefiting patients and society.

ACNU Technology Platform to Pioneer New Nonprescription Drug Approvals and Empower Self-Care.

“According to Towers, some 90% of the data that’s currently “active” in the life sciences and pharmaceuticals industry was created in just the last two years. As the industry trends toward digitizing, the volume of data gathered from customers is “going to explode.”

"Given this substantial Rx ED market, we believe that the prospects of expanded nonprescription access of prescription-grade ED therapy has the potential to significantly multiply this market's growth. With several recently publicized positive OTC switch events, and the potential for applying the principals of AI to ensure that those who are appropriate to receive it do, we have boldly identified this mission of developing STENDRA as the potentially first prescription-grade pharmaceutical available without a prescription, as our primary objective as a company. The company believes that its technology platform designed for this program may also apply to future asset candidates, enabling an expansion to the company's future portfolio and overall opportunity."