{"description":"Documents matching '\"Prescription Drug Use-Related Software\"'","count":5,"total_pages":1,"results":[{"title":"Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Regulatory Considerations for Prescription Drug Use-Related Software.\" This draft guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug- led, drug-device combination product, which is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center.","document_number":"2023-20241","html_url":"https://www.federalregister.gov/documents/2023/09/19/2023-20241/regulatory-considerations-for-prescription-drug-use-related-software-draft-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-09-19/pdf/2023-20241.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-20241.pdf?1695041212","publication_date":"2023-09-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"availability of a draft guidance for industry entitled “Regulatory Considerations for <span class=\"match\">Prescription Drug Use-Related Software</span>.” This draft guidance expands on and was developed in response to comments submitted in response to the \n Federal Register \n notice “<span class=\"match\">Prescription Drug-Use-Related Software</span>; Establishment of a Public Docket; Request for Comments” (November 20, 2018; 83 FR 58574). As explained in this draft guidance, <span class=\"match\">prescription drug use-related software</span> generally includes software that: (1) is disseminated by or on behalf of a drug sponsor"},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Perceptions of Prescription Drug Products With Medication Tracking Capabilities","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2023-09268","html_url":"https://www.federalregister.gov/documents/2023/05/02/2023-09268/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-02/pdf/2023-09268.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-09268.pdf?1682945129","publication_date":"2023-05-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"exploring to track medication use includes the development of software that is disseminated by or on behalf of the drug sponsor and accompanies one or more of the sponsor's prescription drugs. This software is called <span class=\"match\">prescription drug use-related software</span>.\n 1 \n \n Studies exploring drug products with <span class=\"match\">prescription drug use-related software</span> have been conducted with medications to treat an array of chronic disorders, including psychiatric disorders (Ref. 6), uncontrolled type 2 diabetes (Ref. 7), end-stage renal disease requiring transplants (Ref. 8),"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Perceptions of Prescription Drug Products With Medication Tracking Capabilities","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled \"Perceptions of Prescription Drug Products With Medication Tracking Capabilities.\"","document_number":"2022-20636","html_url":"https://www.federalregister.gov/documents/2022/09/23/2022-20636/agency-information-collection-activities-proposed-collection-comment-request-perceptions-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-09-23/pdf/2022-20636.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-20636.pdf?1663850728","publication_date":"2022-09-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"exploring to track medication use includes the development of software that is disseminated by or on behalf of the drug sponsor and accompanies one or more of the sponsor's prescription drugs. This software is called <span class=\"match\">prescription drug use-related software</span>.\n 1 \n \n Studies exploring drug products with <span class=\"match\">prescription drug use-related software</span> have been conducted with medications to treat an array of chronic disorders, including psychiatric disorders (Ref. 6), uncontrolled type 2 diabetes (Ref. 7), end-stage renal disease requiring transplants (Ref. 8),"},{"title":"Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments; Reopening of Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled \"Prescription Drug-Use- Related Software; Establishment of a Public Docket; Request for Comments\" that appeared in the Federal Register of November 20, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.","document_number":"2019-03241","html_url":"https://www.federalregister.gov/documents/2019/02/26/2019-03241/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2019-02-26/pdf/2019-03241.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2019-03241.pdf?1551102322","publication_date":"2019-02-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"ACTION: \n Notice of availability; reopening of comment period. \n \n \n SUMMARY: \n \n The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled “<span class=\"match\">Prescription Drug-Use-Related Software</span>; Establishment of a Public Docket; Request for Comments” that appeared in the \n Federal Register \n of November 20, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.\n \n \n \n DATES: \n FDA is reopening the comment period for the notice published on November 20, 2018 (83 FR 58574)"},{"title":"Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments","type":"Notice","abstract":"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.","document_number":"2018-25206","html_url":"https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-11-20/pdf/2018-25206.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-25206.pdf?1542635119","publication_date":"2018-11-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"purposes of this notice, FDA is focused on the output of <span class=\"match\">prescription drug-use-related software</span>. Because, as used in this notice, “<span class=\"match\">prescription drug-use-related software</span>” refers to software disseminated by or on behalf of a drug sponsor, this proposed framework would not apply to third-party software developers who independently develop or disseminate software for use with prescription drugs. \n The proposed framework is designed to take a risk-based approach to <span class=\"match\">prescription drug-use-related software</span>. Under this approach, it is anticipated that in most"}]}