drjack.world
Google Keyword Rankings for : advertising of unapproveduncleared devices
1
https://www.fdli.org/2018/10/medical-device-crowdfunding-and-pre-approval-promotion-where-does-fda-draw-the-line/
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https://www.fdli.org/2018/10/medical-device-crowdfunding-and-pre-approval-promotion-where-does-fda-draw-the-line/
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2
https://www.greymattermarketing.com/blog/promoting-medical-devices-prior-to-fda-approval-or-clearance
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https://www.greymattermarketing.com/blog/promoting-medical-devices-prior-to-fda-approval-or-clearance
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3
https://gardner.law/alerts/ad-promo-review/was-it-something-i-said-discussions-before-fda-approval/
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https://gardner.law/alerts/ad-promo-review/was-it-something-i-said-discussions-before-fda-approval/
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4
https://centerlinebiomedical.com/2018/03/23/medical-device-advertising-and-promotion-prior-to-fda-approval-or-clearance/
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https://centerlinebiomedical.com/2018/03/23/medical-device-advertising-and-promotion-prior-to-fda-approval-or-clearance/
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5
https://www.mddionline.com/news/displaying-investigational-and-unapproved-medical-devices-according-fda-policy
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https://www.mddionline.com/news/displaying-investigational-and-unapproved-medical-devices-according-fda-policy
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6
https://www.mpo-mag.com/issues/2006-11/view_columns/promoting-medical-devices-prior-to-fda-approval-or-clearance/
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https://www.mpo-mag.com/issues/2006-11/view_columns/promoting-medical-devices-prior-to-fda-approval-or-clearance/
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7
https://www.corporatecomplianceinsights.com/fda-regulation-of-medical-device-advertising-and-promotion/
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https://www.corporatecomplianceinsights.com/fda-regulation-of-medical-device-advertising-and-promotion/
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8
https://www.hoganlovells.com/~/media/hogan-lovells/pdf/2020-pdfs/jan-2020_friedman-layout.pdf
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https://www.hoganlovells.com/~/media/hogan-lovells/pdf/2020-pdfs/jan-2020_friedman-layout.pdf
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9
https://crstoday.com/articles/2020-oct/understanding-on-label-off-label-and-unapproved-products/
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https://crstoday.com/articles/2020-oct/understanding-on-label-off-label-and-unapproved-products/
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10
https://www.bakermckenzie.com/en-/media/files/insight/publications/2020/04/promoting-medical-products-globally_us_170420.pdf
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https://www.bakermckenzie.com/en-/media/files/insight/publications/2020/04/promoting-medical-products-globally_us_170420.pdf
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11
https://www.agg.com/news-insights/publications/fda-has-not-gone-away-when-it-comes-to-unlawful-medical-device-promotion-companies-receive-warning-letters-for-violative-promotional-claims-05-15-2019/
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https://www.agg.com/news-insights/publications/fda-has-not-gone-away-when-it-comes-to-unlawful-medical-device-promotion-companies-receive-warning-letters-for-violative-promotional-claims-05-15-2019/
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12
https://www.mtaa.org.au/advertising-medical-devices
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https://www.mtaa.org.au/advertising-medical-devices
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13
https://www.whistleblowerfirm.com/medical-equipment-fraud/unapproved-medical-devices-and-uses/
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https://www.whistleblowerfirm.com/medical-equipment-fraud/unapproved-medical-devices-and-uses/
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14
https://mdiconsultants.com/pre-market-exhibition-devices/
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https://mdiconsultants.com/pre-market-exhibition-devices/
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15
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
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https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
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16
https://support.google.com/adspolicy/answer/176031?hl=en
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https://support.google.com/adspolicy/answer/176031?hl=en
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17
https://www.americanconference.com/promotional-review-compliance-for-drugs-devices-825l16-phi/wp-content/uploads/sites/800/2016/08/Day1_4.00_Walsh.A..pdf
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https://www.americanconference.com/promotional-review-compliance-for-drugs-devices-825l16-phi/wp-content/uploads/sites/800/2016/08/Day1_4.00_Walsh.A..pdf
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18
https://www.govinfo.gov/content/pkg/CHRG-110shrg49768/html/CHRG-110shrg49768.htm
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https://www.govinfo.gov/content/pkg/CHRG-110shrg49768/html/CHRG-110shrg49768.htm
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19
https://irb.ucsf.edu/investigational-devices
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https://irb.ucsf.edu/investigational-devices
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20
https://hpm.com/wp-content/uploads/2016/10/Promoting510kPendingDevice.pdf
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https://hpm.com/wp-content/uploads/2016/10/Promoting510kPendingDevice.pdf
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21
http://www.duvalfdalaw.com/clientAlerts/DuVal_Client_Alert_V09_I02_Lawful_Pre_Approval_And_Pre_Clearance_Communication.pdf
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http://www.duvalfdalaw.com/clientAlerts/DuVal_Client_Alert_V09_I02_Lawful_Pre_Approval_And_Pre_Clearance_Communication.pdf
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22
https://research.virginia.edu/irb-hsr/expanded-access-unapproved-medical-devices
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https://research.virginia.edu/irb-hsr/expanded-access-unapproved-medical-devices
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23
https://www.launchteaminc.com/blog/marketing-a-medical-device-101
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https://www.launchteaminc.com/blog/marketing-a-medical-device-101
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24
https://www.cnn.com/2016/11/11/health/fda-hearings-off-label-drugs
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https://www.cnn.com/2016/11/11/health/fda-hearings-off-label-drugs
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25
https://www.aaos.org/contentassets/1cd7f41417ec4dd4b5c4c48532183b96/1177-physician-directed-use-of-medical-products.pdf
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https://www.aaos.org/contentassets/1cd7f41417ec4dd4b5c4c48532183b96/1177-physician-directed-use-of-medical-products.pdf
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26
https://www.hklaw.com/en/insights/publications/2022/01/fda-outlines-post-pandemic-plan-for-medical-devices
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https://www.hklaw.com/en/insights/publications/2022/01/fda-outlines-post-pandemic-plan-for-medical-devices
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27
https://www.jstor.org/stable/26660477
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https://www.jstor.org/stable/26660477
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28
https://eprostarchive.med.miami.edu/Eprost/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B9C72738B1762C347B3350706BDD58021%5D%5D
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https://eprostarchive.med.miami.edu/Eprost/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B9C72738B1762C347B3350706BDD58021%5D%5D
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29
https://www.drugwatch.com/fda/510k-clearance/
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https://www.drugwatch.com/fda/510k-clearance/
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30
https://www.kslaw.com/attachments/000/005/699/original/ca022318.pdf?1520518325
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https://www.kslaw.com/attachments/000/005/699/original/ca022318.pdf?1520518325
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31
https://www.tga.gov.au/sites/default/files/advertising-for-medical-devices.pdf
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https://www.tga.gov.au/sites/default/files/advertising-for-medical-devices.pdf
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32
https://www.jdsupra.com/legalnews/fda-issues-final-rule-clarifying-3589840/
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https://www.jdsupra.com/legalnews/fda-issues-final-rule-clarifying-3589840/
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33
https://www.advamed.org/wp-content/uploads/2019/04/advamed-guiding-principles-for-direct-to-consumer-device-advertising.pdf
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https://www.advamed.org/wp-content/uploads/2019/04/advamed-guiding-principles-for-direct-to-consumer-device-advertising.pdf
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34
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/fulltext.html
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https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/fulltext.html
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35
https://www.dentons.com/en/insights/articles/2022/october/3/italy-introduces-new-rules-regarding-medical-devices-and-in-vitro-diagnostic-medical-devices
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https://www.dentons.com/en/insights/articles/2022/october/3/italy-introduces-new-rules-regarding-medical-devices-and-in-vitro-diagnostic-medical-devices
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36
https://journalofethics.ama-assn.org/article/how-differently-should-fda-regulate-drugs-and-devices/2021-09
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https://journalofethics.ama-assn.org/article/how-differently-should-fda-regulate-drugs-and-devices/2021-09
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37
https://www.sidley.com/~/media/files/publications/2011/03/offlabel-prescription-advertising-the-fda-and-th__/files/view-article/fileattachment/ssrnid1793338.pdf
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https://www.sidley.com/~/media/files/publications/2011/03/offlabel-prescription-advertising-the-fda-and-th__/files/view-article/fileattachment/ssrnid1793338.pdf
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38
https://www.omic.com/when-fda-leaves-doctors-to-their-own-devices/
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https://www.omic.com/when-fda-leaves-doctors-to-their-own-devices/
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39
https://www.sciencedirect.com/science/article/pii/S2452302X16300183
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https://www.sciencedirect.com/science/article/pii/S2452302X16300183
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40
https://asiaactual.com/blog/medical-device-advertising-requirements-in-asia/
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https://asiaactual.com/blog/medical-device-advertising-requirements-in-asia/
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41
https://research.uci.edu/human-research-protections/clinical-research/devices-used-in-clinical-research/expanded-access-to-unapproved-medical-devices/
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https://research.uci.edu/human-research-protections/clinical-research/devices-used-in-clinical-research/expanded-access-to-unapproved-medical-devices/
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42
https://www.regulations.gov/document/FDA-2022-N-0175-0001
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https://www.regulations.gov/document/FDA-2022-N-0175-0001
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43
https://ora.research.ucla.edu/OHRPP/Documents/Policy/8/Devices_in_Research.pdf
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https://ora.research.ucla.edu/OHRPP/Documents/Policy/8/Devices_in_Research.pdf
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44
https://tracs.unc.edu/docs/regulatory/IDE_FDA_Guidance_and_FAQs.pdf
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https://tracs.unc.edu/docs/regulatory/IDE_FDA_Guidance_and_FAQs.pdf
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45
https://www.ebglaw.com/wp-content/uploads/2014/06/29857_AMA.ppt
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https://www.ebglaw.com/wp-content/uploads/2014/06/29857_AMA.ppt
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46
https://www.skadden.com/insights/publications/2021/08/fdas-final-rule-on-intended-use
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https://www.skadden.com/insights/publications/2021/08/fdas-final-rule-on-intended-use
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47
https://irb.northwestern.edu/docs/guidance-on-the-use-of-investigational-medical-devices-in-human-subjects-research.pdf
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https://irb.northwestern.edu/docs/guidance-on-the-use-of-investigational-medical-devices-in-human-subjects-research.pdf
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48
https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gn-08-r2-guidance-on-medical-device-advertisements-and-sales-promotion.pdf
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https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gn-08-r2-guidance-on-medical-device-advertisements-and-sales-promotion.pdf
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49
https://www.sedgwick.com/blog/2021/06/02/doj-increasing-enforcement-on-off-label-promotion-heres-what-to-expect
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https://www.sedgwick.com/blog/2021/06/02/doj-increasing-enforcement-on-off-label-promotion-heres-what-to-expect
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50
https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/united-kingdom
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https://cms.law/en/int/expert-guides/cms-expert-guide-to-advertising-of-medicines-and-medical-devices/united-kingdom
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51
https://clinicaltrials.gov/ct2/manage-recs/faq
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https://clinicaltrials.gov/ct2/manage-recs/faq
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52
https://www.jmcp.org/doi/pdf/10.18553/jmcp.2011.17.1.40
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https://www.jmcp.org/doi/pdf/10.18553/jmcp.2011.17.1.40
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53
https://depisteo.com/blog/do-all-medical-devices-need-fda-approval/
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https://depisteo.com/blog/do-all-medical-devices-need-fda-approval/
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54
https://www.phillipsandcohen.com/off-label-marketing/
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https://www.phillipsandcohen.com/off-label-marketing/
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55
https://oig.hhs.gov/reports-and-publications/top-challenges/2011/issue12.asp
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https://oig.hhs.gov/reports-and-publications/top-challenges/2011/issue12.asp
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56
https://www.regdesk.co/updated-sfda-guidance-on-medical-devices-advertising/
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https://www.regdesk.co/updated-sfda-guidance-on-medical-devices-advertising/
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57
https://www.aspenlaser.com/the-difference-between-fda-registered-fda-approved-and-fda-cleared/
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https://www.aspenlaser.com/the-difference-between-fda-registered-fda-approved-and-fda-cleared/
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58
https://www.federalregister.gov/documents/2021/08/02/2021-15980/regulations-regarding-intended-uses
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https://www.federalregister.gov/documents/2021/08/02/2021-15980/regulations-regarding-intended-uses
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59
https://www.lexology.com/library/detail.aspx?g=656bb27b-0a3f-4f60-909c-3143b90bcbe3
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https://www.lexology.com/library/detail.aspx?g=656bb27b-0a3f-4f60-909c-3143b90bcbe3
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60
https://www.medsafe.govt.nz/compliance/advertising.asp
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https://www.medsafe.govt.nz/compliance/advertising.asp
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61
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
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https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
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62
https://www.frierlevitt.com/articles/service/pharmacylaw/doj-position-on-off-label-promotion-whats-changed-and-whats-the-same/
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https://www.frierlevitt.com/articles/service/pharmacylaw/doj-position-on-off-label-promotion-whats-changed-and-whats-the-same/
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63
https://www.bmj.com/content/353/bmj.i3323
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https://www.bmj.com/content/353/bmj.i3323
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64
https://www.health.ny.gov/professionals/patients/medicines/prescription/comments_submitted_to_the_fda.htm
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https://www.health.ny.gov/professionals/patients/medicines/prescription/comments_submitted_to_the_fda.htm
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65
https://www.cms-lawnow.com/-/media/lawnow/pdfs/mawe/cms---advertising-of-medicines-and-medical-devices.pdf?rev=3126c1ab-5901-4e57-a78a-babbfbd6468f&la=en&hash=C1E85C3AB45CC9E4C6AA654A723BD0F57EDE20C0
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https://www.cms-lawnow.com/-/media/lawnow/pdfs/mawe/cms---advertising-of-medicines-and-medical-devices.pdf?rev=3126c1ab-5901-4e57-a78a-babbfbd6468f&la=en&hash=C1E85C3AB45CC9E4C6AA654A723BD0F57EDE20C0
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66
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c14.pdf
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https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c14.pdf
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67
https://www.registrarcorp.com/how-to-get-fda-approval/
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https://www.registrarcorp.com/how-to-get-fda-approval/
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68
https://www.hrpo.pitt.edu/policies-and-procedures/expanded-access-unapproved-drugs-biologics-or-devices
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https://www.hrpo.pitt.edu/policies-and-procedures/expanded-access-unapproved-drugs-biologics-or-devices
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69
https://www.justice.gov/opa/pr/vascular-solutions-inc-and-its-ceo-charged-selling-unapproved-medical-devices-and-conspiring
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https://www.justice.gov/opa/pr/vascular-solutions-inc-and-its-ceo-charged-selling-unapproved-medical-devices-and-conspiring
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70
https://portal.mda.gov.my/documents/guidance-documents/1507-advertisement-for-medical-device-requirements/file.html
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https://portal.mda.gov.my/documents/guidance-documents/1507-advertisement-for-medical-device-requirements/file.html
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71
https://learn.marsdd.com/article/unlicensed-healthcare-products-no-advertising-or-promotion-allowed/
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https://learn.marsdd.com/article/unlicensed-healthcare-products-no-advertising-or-promotion-allowed/
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72
https://irb.emory.edu/_includes/documents/sections/guidance-irb-review-of-medical-device-research.pdf
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https://irb.emory.edu/_includes/documents/sections/guidance-irb-review-of-medical-device-research.pdf
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73
https://elsmar.com/elsmarqualityforum/threads/promoting-and-marketing-of-a-non-approved-device.81256/
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https://elsmar.com/elsmarqualityforum/threads/promoting-and-marketing-of-a-non-approved-device.81256/
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74
https://www.law.cornell.edu/uscode/text/21/352
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https://www.law.cornell.edu/uscode/text/21/352
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75
https://www.researchgate.net/publication/6792924_Advertising_and_promotion_of_medical_devices
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https://www.researchgate.net/publication/6792924_Advertising_and_promotion_of_medical_devices
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76
https://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1130&context=healthmatrix
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https://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1130&context=healthmatrix
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77
https://www.rcclaw.com/understanding-the-difference-between-fda-approved-and-fda-cleared-is-crucial-to-defective-medical-device-litigation/
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https://www.rcclaw.com/understanding-the-difference-between-fda-approved-and-fda-cleared-is-crucial-to-defective-medical-device-litigation/
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78
https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/usa
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https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/usa
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79
https://www.loeb.com/~/media/files/pdfs/loeb%20social%20media_life%20sciences%20presentation.pdf
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https://www.loeb.com/~/media/files/pdfs/loeb%20social%20media_life%20sciences%20presentation.pdf
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80
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30292-2/fulltext
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https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30292-2/fulltext
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81
https://dicentra.com/blog/canada-2/health-canada-illegal-marketing-of-drugs-and-devices-program
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https://dicentra.com/blog/canada-2/health-canada-illegal-marketing-of-drugs-and-devices-program
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82
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83
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84
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86
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87
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88
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89
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92
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94
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95
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