federal_register: 2018-25206
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2018-25206 | Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments | Notice | The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. Recognizing the opportunities for increased use of digital technology with prescription drugs, the Agency is proposing a framework that would provide prescription drug sponsors the flexibility to develop and disseminate innovative software, while maintaining appropriate Agency oversight over the sponsors' communications about their products. The framework proposed in this notice focuses not on prescription drug-use-related software itself, but rather on the output of such software that is presented to the end user. For purposes of the notice, prescription drug-use-related software refers to software disseminated by or on behalf of a drug sponsor that accompanies one or more of the sponsor's prescription drugs (including biological drug products). Software that is developed for use with prescription drugs but is not disseminated by or on behalf of a drug sponsor is not addressed in this proposal. The proposed framework is being issued for discussion purposes only and is not a draft guidance. This document is not intended to communicate FDA's proposed (or final) regulatory expectations but is instead meant to seek early input from groups and individuals outside the Agency prior to development of a draft guidance. | 2018-11-20 | 2018 | 11 | https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments | https://www.govinfo.gov/content/pkg/FR-2018-11-20/pdf/2018-25206.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or... |