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In the News: September Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program.

FDA Establishes Digital Health Center of Excellence

The FDA announced the launch of its Digital Health Center of Excellence (DHCoE) on September 22, marking an important step in its efforts to modernize digital health policies and regulatory approaches. FDA Commissioner Stephen M. Hahn, MD, stated that the establishment of the DHCoE “will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.” According to the FDA, the DHCoE has three objectives:

  • Connecting and building partnerships to accelerate digital health advancements
  • Sharing knowledge to increase awareness and understanding, drive synergy, and advance best practices
  • Innovating regulatory approaches to provide efficient and least burdensome oversight while meeting FDA standards

The establishment of the DHCoE is the latest of many signs that the FDA is working closely with other stakeholders to make sure that regulations keep pace with the rapid advancements in this space. Multiple guidance documents have been released in the last several years outlining the FDA’s current thinking on specific digital health products, such as software as a medical device (SaMD) and mobile medical applications. The FDA has also recently launched the Software Pre-Certification Pilot Program to provide an efficient regulatory framework for developers of SaMD products.

The FDA is planning two listening sessions to allow manufacturers, developers, health care providers, researchers, and other interested parties to learn more about the purpose and function of the DHCoE. Sign up here for the October or November listening sessions.

FDA Issues Guidances Dealing with ANDAs

The FDA issued two guidances near the end of September, almost companion documents, both dealing with ANDAs.

Failure to Respond to an ANDA Complete Letter Within the Regulatory Timeframe

The first, “Failure to Respond to an ANDA Complete Letter Within the Regulatory Timeframe,” briefly walks through the process of how such a failure plays out. The FDA says that the significant increase in ANDA applications falling into this category has negatively impacted the Agency in a variety of ways.

Following the review of an ANDA, if the FDA determines that the application fails to meet the regulatory requirements for approval, the Agency issues a Complete Response Letter (CRL), which specifies the deficiencies preventing the application’s approval. The applicant then has one year to resubmit the application, addressing the shortcomings specified in the CRL. Historically, the FDA has liberally granted extensions to the one-year period.

In the guidance, the FDA says it will respond to such failures going forward with notifications to applicants that they have 30 days to provide justification for why the application should not be considered withdrawn and to request an extension. Requests for additional extensions will be handled in a similar fashion.

It is not clear why there is an increase in the failures to respond to CRLs. They can seem daunting when they arrive, but Camargo can assist in evaluating and responding to a CRL in order to achieve ANDA approval and avoid the problems listed in the guidance.

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

The second guidance, “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs,” deals with the not uncommon situation wherein an ANDA application has received tentative approval because of a Paragraph III patent certification in the original application. ANDA applications rely on an approved product, provided in the FDA’s Orange Book as the Reference Listed Drug (RLD). As part of the original ANDA application, the sponsor must provide a Patent Certification for any patents listed in the Orange Book for the RLD.

The guidance focuses on “Paragraph III certification,” where the sponsor acknowledges that there are patents listed in the Orange Book which block the approval of the ANDA and agrees to wait for final approval of the application until the terms of the listed patents have expired. If the FDA determines that the contents of the ANDA meet regulatory requirements, the application receives “tentative approval,” or acknowledgement that the application meets requirements for approval except for the RLD patent(s) blocking it.

There can be a substantial period of time between the granting of tentative approval and the end of the patent term(s). In that space, circumstances can arise that require that the tentatively approved ANDA be amended. Once the patent terms have expired, the applicant needs to submit a request to the FDA to grant full approval to the tentatively approved ANDA.

The guidance discusses the possible impact that amendments to the ANDA application following the granting of tentative approval can have on the granting of final approval. It also outlines the correct procedure for requesting final approval. In this situation, the timing and content of amendments following tentative approval can be complicated; Camargo can help sponsors navigate the process.

Approval of the Month: FDA Approves First Closed-Loop Monitoring and Drug Delivery Device

The FDA has announced its approval of a bluetooth-controlled insulin delivery and monitoring system for use in pediatric patients ages 2 through 6 with Type 1 diabetes. Medtronic made some modifications to its currently approved insulin pump and developed a smartphone app to control the delivery of insulin based on the measurement of insulin levels every 5 minutes.

According to the FDA announcement, the system includes a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump strapped to the body, and an infusion patch connected to the pump with a catheter that delivers insulin. Although the device automatically adjusts insulin levels, patients or their caregivers need to request insulin doses manually to counter carbohydrate consumption at mealtime.

This closed-loop system is the first of its kind and portends future closed-loop systems for other diseases. Medtronic and the FDA have laid out the groundwork for gaining approval for such systems. The single clinical study enrolled 46 children aged 2 to 6 years old with Type 1 diabetes. These patients along with their caregivers were studied for three months, both at home and in a hotel setting, with a stress test of sustained daily exercise. Approval came with a required post-marketing commitment to evaluate the device’s performance in the real world.

Camargo has worked with several companies on pump delivery systems and is at the forefront of digital therapy innovation. Contact us to find out how we can support your program.

Co-Authors:

Ken Phelps
President and Founder

Bill Stoltman, JD
Vice President of Regulatory Operations

Shauna Swanson, PhD
Regulatory Scientist