Introduction
The Prescription Drug User Fee Act VII (PDUFA VII) commitment letter represents the product of discussions between the Food and Drug Administration (FDA), regulated industry, and public stakeholders, as mandated by Congress. The performance and procedural goals and other commitments specified in the PDUFA VII commitment letter apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. The commitment letter includes goals relating to the use of digital health technologies (DHTs) to support drug development and review. Among other activities relating to the use of DHTs, under section IV.C.1 of the commitment letter, FDA has established a Framework for the Use of DHTs in Drug and Biological Product Development to guide the use of DHT-derived data in regulatory decision-making for drugs (hereinafter “Framework”).
This document outlines the Framework that FDA will use to implement a multifaceted DHT program for drugs. The DHT program will include workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents. This document is not a guidance document and does not propose or establish policies.
Scope
The Framework includes the following activities outlined in the PDUFA VII commitment letter:
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