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P101: FDA’s Approach to Fulfilling PDUFA VII Commitments Related to Use of Digital Health Technologies to Support Drug Development

Poster Presenter

Kayla Garvin

Sr Regulatory Health Project Manager
FDA
United States

Objectives

To provide an overview of the current state of FDA’s efforts to fulfill PDUFA VII commitments related to the use of digital health technologies (DHTs) to support drug development and review.

Method

FDA is committed to meeting PDUFA VII goals that including activities focused on use of DHTs in drug development. FDA leveraged expertise from CDER’s Office of Medical Policy, Office of Strategic Programs, Office of Translational Sciences and CDRH’s Digital Center of Excellence to meet these goals.

Results

FDA met the FY23 commitments related to DHTs in drug development and is on track to complete future commitments. PDUFA VII DHT commitments are: •By the end of Q1 FY 2023, publish guidance on the use of DHTs in traditional and decentralized clinical trials •By the end of Q2 FY 2023, oestablish a framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products oestablish a committee to support implementation of the commitments oconvene the first of a series of 5 public meetings or workshops to gather input into issues related to the use of DHTs in regulatory decision-making •By the end of FY 2023, publish guidance on regulatory considerations for Prescription Drug Use-Related Software •Identify at least 3 issue-focused demonstration projects to inform methodologies for efficient DHT evaluation •Expand capacity to achieve objectives and to enhance consistency across the human drugs and biologics program with regards to development, use, and review of DHT’s •Enhance IT capabilities to support review of DHT-generated data FDA has completed the following: •Established the DHT Steering Committee in May 2022 •Published the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in March 2023 •Held public meeting “Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review” in March 2023 •Published draft guidance “Digital Health Technologies for Remote Acquisition in Clinical Investigations” in December 2021 and finalized in December 2023 •Published draft guidance “Regulatory Considerations for Prescription Drug Use-Related Software” in September 2023 •Funded 2 demonstration projects in FY23 •Leveraged DHT Steering Committee and internal FDA opportunities to provide transparency and training •Updated Standard Form 1571 and 356H to include reporting of DHT use in FDA submissions.

Conclusion

Digital health technologies (DHTs) offer potential benefits in the clinical development of medical products. Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial data directly from patients. PDUFA VII lists several activities related to DHTs for drug development and review, which FDA has committed to undertake. These include: •Publishing a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development •Establishing a DHT Steering Committee •Convening Public Meetings •Identifying Demonstration Projects Implementation of these commitments by FDA is supporting increased consistency across centers in policies, procedures, and analytic approaches related to DHTs. Priorities include increasing the diversity of participants in clinical trials through the use of DHTs and improving measurement of responses to treatment. Through implementation of guidance, the FDA has communicated its current thinking on the use of DHTs for remote data acquisition in clinical investigations and the use of DHTs in decentralized clinical trials. Standard FDA forms have been modified, allowing sponsors to report clinical trials where DHTs are used. This information will be used by FDA to track the numbers of submissions involving the use of DHTs over time. The accomplishments thus far will lead to a better understanding of the use of DHTs to support drug development and review.