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Breakthrough Devices Program | FDA
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
WEBSep 14, 2023 · request for discussion on a data development plan, and; request for clinical protocol agreement. Learn more about these options in Section IV of the Breakthrough Devices Program guidance.
DA: 73 PA: 40 MOZ Rank: 87
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Discussion Guide: FDA’s Data Enterprise Modernization
https://healthpolicy.duke.edu/sites/default/files/2021-08/Discussion%20Guide_FDA%27s%20Enterprise%20Data%20Modernization.pdf
WEBThe FDA’s Data Modernization Action Plan (DMAP) Data Modernization Action Plan (fda.gov), which launched in March 2021, is a key foundational framework to guide the …
DA: 17 PA: 3 MOZ Rank: 97
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Food and Drug Administration Data and Technology Strategic …
https://www.federalregister.gov/documents/2023/04/13/2023-07766/food-and-drug-administration-data-and-technology-strategic-plan-request-for-information-and-comments
SummaryDatesFor Further Information ContactSupplementary Information I. BackgroundFDA is announcing the availability of a request for information and comments entitled “FDA Data and Technology Strategic Plan; Request for Information and Comments.” The Office of Digital Transformation (ODT) was established in September 2021 and reports directly to the Office of t… II. Requested Information and CommentsInterested persons are invited to provide detailed comments to ODT (see ADDRESSES ) on the following aspects of the development of FDA's Agency-wide Data and Technology Strategic Plan. To facilitate input, FDA has developed a series of questions in this section. The questions are n…
I. BackgroundFDA is announcing the availability of a request for information and comments entitled “FDA Data and Technology Strategic Plan; Request for Information and Comments.” The Office of Digital Transformation (ODT) was established in September 2021 and reports directly to the Office of t…
II. Requested Information and CommentsInterested persons are invited to provide detailed comments to ODT (see ADDRESSES ) on the following aspects of the development of FDA's Agency-wide Data and Technology Strategic Plan. To facilitate input, FDA has developed a series of questions in this section. The questions are n…
DA: 7 PA: 21 MOZ Rank: 21
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FDA Unveils Data Modernization Plan – Policy & Medicine
https://www.policymed.com/2021/04/fda-unveils-data-modernization-plan.html
WEBApr 8, 2021 · The FDA data plan will leverage the foundations laid by TMAP: a modern, cloud-forward technical infrastructure; a product-oriented approach, and enhanced …
DA: 2 PA: 29 MOZ Rank: 60
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FDA’s Enterprise Data Modernization - Duke University
https://healthpolicy.duke.edu/sites/default/files/2021-08/Agenda_FDA%27s%20Enterprise%20Data%20Modernization.pdf
WEBThe FDA’s Data Modernization Action Plan (DMAP) Data Modernization Action Plan (fda.gov), which launched in March 2021, is a key foundational framework to guide the …
DA: 9 PA: 99 MOZ Rank: 13
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FDA lays out data modernization action plan | MedTech Dive
https://www.medtechdive.com/news/fda-lays-out-data-modernization-action-plan/596114/
WEBMar 4, 2021 · Dive Brief: FDA has shared a Data Modernization Action Plan setting out its response to the proliferation and diversification of data sources. Through DMAP, FDA …
DA: 16 PA: 15 MOZ Rank: 64
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Data-Sharing, AI, Collaboration Prioritized in FDA IT …
https://www.fdanews.com/articles/212678-data-sharing-ai-collaboration-prioritized-in-fda-it-modernization-plan
WEBOctober 11, 2023. The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data …
DA: 43 PA: 52 MOZ Rank: 62
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Data Development Plan Example 1 - fda.report
https://fda.report/media/100623/Data-Development-Plan-Example-1.pdf
WEBdevices only) explanation and justification for proposed balance of premarket and postmarket data collection including a description of the type of data to be included in …
DA: 30 PA: 24 MOZ Rank: 18