PDURS: How 7 Companies and Groups Responded to the Draft Guidelines

Jul 22, 2024

The FDA’s Draft Guidelines for Prescription Drug Use Related Software (PDURS) have sparked considerable discussion among various stakeholders, including pharmaceutical companies, healthcare organizations, and digital health advocates. While praising and supporting the FDA’s work to issue clear guidance, most also had specific requests for additional clarity, especially about clinical trial requirements for digital health software…

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Health Journey

PDURS: Insights for Pharma’s Digital Health and Innovation Teams

Jul 19, 2024

The FDA’s new Draft Guidelines for Prescription Drug Use Related Software (PDURS) are shaping the future of digital health in the pharmaceutical industry. These guidelines aim to ensure the safety and efficacy of software that supports prescription drug use, marking a pivotal moment for digital health professionals. As executives at the forefront of pharmaceutical digital…

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PDURS: How Pharma Brand Marketing, Procurement Teams Can Prepare

Jul 18, 2024

As the digital health landscape evolves, pharmaceutical companies must adapt to new regulatory frameworks that ensure patient safety and product efficacy. The FDA’s Draft Guidelines for Prescription Drug Use Related Software (PDURS) mark a significant step in this direction, providing comprehensive standards for software intended to support prescription drug use. For pharmaceutical brand marketers and…

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time change

PDURS: Background and Latest Rollout Timeline

Jul 17, 2024

In an era where digital health tools are becoming increasingly integrated into healthcare delivery, regulatory frameworks must adapt to ensure these innovations are safe, effective, and beneficial to patients. The FDA’s Prescription Drug Use Related Software (PDURS) guidance is a significant step in this direction. This guidance focuses on software intended to support the use…

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integrated health

PDURS: 6 Ways Patients Will Benefit from FDA’s Draft Software Guidelines

Jul 16, 2024

Understanding the New FDA Guidelines for Prescription Drug Use-Related Software  (PDURS) In today’s world, technology is becoming more integrated into our daily lives, making many tasks easier and more efficient. One of the recent advancements in healthcare is the development of software designed to help manage and improve the use of prescription drugs. The U.S.…

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Medisafe at Pharma USA

Feb 27, 2024

Don’t leave Pharma USA without the right partner See what we’re talking about at Pharma USA: Medisafe is the leading medication engagement platform that empowers patients to seamlessly manage their treatment journey. We engage one patient at a time, but at scale, guided through our advanced technology to build a future model of patient support…

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Medisafe and Infinitus

Pharmaceutical Companies Can Now Use AI to Streamline the Patient Experience with Medisafe and Infinitus

Feb 27, 2024

Leading pharmaceutical companies are now using AI to help healthcare providers simplify and streamline the patient experience for specialty medications, which can be difficult to access, adhere to, and afford.  Consider this example: One adolescent Crohn’s disease patient must take 12 medications at different times of the day, which is difficult for him and his…

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Novel Randomized Control Trial Reveals Impact of Medisafe on Medication Self-Efficacy and Medication Adherence to Improve Health Outcomes in Medically Underserved Populations

Feb 13, 2024

BOSTON // February 13, 2024/ A novel randomized control trial conducted by Vanderbilt University researchers and published in the Journal of Behavioral Medicine explored the effect of smartphone applications on medication adherence in a medically underserved population.  The trial concluded that Medisafe’s free and accessible app provides a transformative impact on medication adherence and medication…

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Weight Management

Transforming Weight Loss in the Digital Age: A $260.6 Billion Challenge

Feb 9, 2024

By Stacey Wasserman Chief Business Officer Weight management is a global concern affecting 650 million people, with four million annual deaths attributed to obesity, according to the World Health Organization. In the United States alone, the annual cost of obesity-related medical care was estimated at nearly $260.6 billion. Addressing this challenge requires innovative solutions, and…

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Data Pulse: A Five-Time Increase in Use of Medisafe for Obesity Meds

Jan 24, 2024

Weight Management affects 650M people worldwide. Four million people die each year as a result of obesity, according to the World Health Organization [1], making it a serious global problem. Annual obesity-related medical care costs in the United States, were estimated to be $260.6B. In the last 5 years, the popularity of medications that Medisafe…

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