In September, the Food and Drug Administration (FDA) announced a groundbreaking move by progressing its proposed ‘Prescription Drug Use Related Software’ (PDURS) framework through the publication of draft guidance. This framework delineates a clear regulatory pathway for software intended to accompany prescription drugs, marking a positive step in the convergence of drug and digital technologies.

Closed Loop Medicine is a drug dose optimization company developing new, differentiated drug + digital combination products, underpinned by dosing IP. Each patient responds differently to therapy, many experience Adverse Events that require different titration schedules. However, healthcare professionals don’t have time to guide every dose change. This is confusing for patients and can create a negative care experience, resulting in poor adherence, treatment discontinuation and even switching to an alternative therapy. The Company’s approach has been to use software to guide, optimize and automate these changes.

The PDURS draft guidance underscores the FDA’s recognition of the intrinsic value of drug + digital product integration and lays the groundwork for streamlined regulatory approval processes for these innovative products. With regulatory support and an expanding pool of promising data, the new generation of software-driven TechBio companies is poised to reshape the industry landscape by leveraging the FDA’s recent regulatory development. As the next phase of healthcare innovation is unfolding, we are steering towards a future where the integration of digital solutions into patient care becomes not just a possibility, but a necessity.

Since the publication of FDA’s initial proposed framework in 2018, Closed Loop Medicine has paid close attention to the development of this framework and is strongly encouraged by the publication of the recent draft guidance. The Company has crafted its own US regulatory strategy in alignment with this forward-thinking framework and proactively been engaging with the FDA through pre-submissions, strategically positioning itself to take advantage of these updated guidelines once finalized.

Jim Baker, the Company’s Senior Director of Quality and Regulatory Affairs, emphasized the significance of the FDA’s recent draft guidance, stating, “This represents an exciting step in realization of Closed Loop Medicine’s vision of drug + digital products, combined through labeling. Our regulatory strategy is tailored to complement the direction set forth by the PDURS framework, and our proactive interactions with the FDA underscore our mission to ensure that our innovative solutions can be integrated with our partners’ drug products in a seamless fashion”.

The clarity provided by this framework, coupled with Closed Loop Medicine’s track record in the development of Software-as-a-Medical-Device (SaMD), positions the organization as a significant player in the dynamic drug + digital space. With a commitment to establishing partnerships and demonstrating clinically meaningful benefits for its products, this approach stands ready to navigate the device clearance and approval process. The convergence of regulatory support and industry innovation is paving the way for a new era in digital therapeutics, and Closed Loop Medicine is at the forefront of this transformative journey.

For more information on our pioneering initiatives in the development of combination prescription drug plus software therapy products, visit