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Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments
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Summary (from the Federal Register abstract)
Digital health technologies (DHTs) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research. As outlined in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VII) included as part of the FDA User Fee Reauthorization Act of 2022, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have committed to supporting the use of DHTs in drug and biological product development. To inform potential FDA activities in this area, CDER and CBER are requesting information to better understand the opportunities and challenges sponsors and other interested parties face in making innovative use of DHTs in clinical investigations of drugs and biological products.
- Document type
- Notice
- Federal Register document number
- 2026-06184
- Published
- Mar 31, 2026
- Action
- Notice; Request for information and comments.
- Docket
- FDA-2026-N-2476
- Comments posted on Regulations.gov (at last check)
- 41
- DATES section (from the document)
- Either electronic or written comments must be submitted by June 1, 2026.
- Topics (auto-tagged)
- Clinical Vaccines / biologics
Source: Federal Register API, document 2026-06184. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.