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1
https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/off-label-marketing-factsheet.pdf
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2
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799128/
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3
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7
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8
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9
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10
https://www.skadden.com/insights/publications/2021/04/enforcement-in-life-sciences-series/dojs-evolving-enforcement-approach
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https://www.theregreview.org/2017/10/18/whisenant-fda-off-label-promotion/
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17
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18
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19
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20
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22
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23
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24
https://www.ebglaw.com/wp-content/uploads/2014/06/26740_HCPro-Web-Cast-12_20_07-_Medical-Device-Promotion-Avoid-Off_label-pitfalls.ppt
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25
https://www.nejm.org/doi/full/10.1056/nejmp0802107
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26
https://scholars.law.unlv.edu/cgi/viewcontent.cgi?article=2060&context=facpub
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27
https://www.cliffordchance.com/content/dam/cliffordchance/briefings/2012/03/a_comparative_review_of_off_label_pharmaceutical_use_and_promotion_in_europe__the_us_and_china.pdf
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28
https://www.aaos.org/contentassets/1cd7f41417ec4dd4b5c4c48532183b96/1177-physician-directed-use-of-medical-products.pdf
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29
https://bergermontague.com/how-to-recognize-fraud-applying-the-false-claims-act-to-off-label-marketing/
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30
https://www.statnews.com/topic/off-label-marketing/
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31
https://www.kytrial.com/blog/2016/february/financial-effects-of-off-label-marketing/
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32
https://harrisbricken.com/psychlawblog/ketamine-and-off-label-issues/
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33
https://www.sedgwick.com/blog/2021/06/02/doj-increasing-enforcement-on-off-label-promotion-heres-what-to-expect
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34
https://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1315&context=caselrev
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35
https://clarivate.com/blog/shifts-in-the-fdas-approach-to-off-label-promotion/
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36
https://www.fiercepharma.com/marketing/drugmakers-to-fda-let-us-share-off-label-data-payers
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37
https://uknowledge.uky.edu/cgi/viewcontent.cgi?article=1045&context=law_facpub
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38
https://kkc.com/frequently-asked-questions/reporting-off-label-drug-marketing/
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39
https://sgp.fas.org/crs/misc/R45792.pdf
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40
https://www.tga.gov.au/resources/resource/guidance/label-use-medical-devices-frequently-asked-questions
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41
https://heigos.hypotheses.org/11024
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42
https://content.next.westlaw.com/practical-law/document/I8417d6531cb111e38578f7ccc38dcbee/Off-label-use-of-medicinal-products-a-legal-update?viewType=FullText&transitionType=Default&contextData=(sc.Default)
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43
https://jaapl.org/content/early/2020/11/24/JAAPL.200049-20
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44
https://cohenhealthcarelaw.com/fda-ftc-law/off-label-use/
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45
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46
https://cdn.pfizer.com/pfizercom/White-Guide-Combine-01-20-2022.pdf
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https://scholar.smu.edu/cgi/viewcontent.cgi?article=1005&context=law_faculty
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48
https://www.ojp.gov/ncjrs/virtual-library/abstracts/first-amendment-and-regulation-pharmaceutical-marketing-challenges
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49
https://www.fdli.org/2017/10/compounding-off-label-promotion-debate-fda-regulate-promotion-unapproved-drugs/
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50
https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/usa
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51
https://academic.oup.com/jlb/article/2/3/705/1918077
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52
https://ag.ny.gov/press-release/2016/ag-schneiderman-announces-195-million-multi-state-agreement-bristol-myers-squibb
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53
https://www.drugwatch.com/featured/big-pharma-marketing/
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54
https://scholarship.law.ufl.edu/cgi/viewcontent.cgi?article=1928&context=flr
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55
https://chicagounbound.uchicago.edu/cgi/viewcontent.cgi?article=5861&context=uclrev
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56
https://www.amcp.org/policy-advocacy/policy-advocacy-focus-areas/where-we-stand-position-statements/label-use-pharmaceuticals
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57
https://openscholarship.wustl.edu/law_journal_law_policy/vol60/iss1/19/
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58
https://www.socialmediatoday.com/content/fda-guidance-pharma-social-media-and-label-use
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59
https://www.ajmc.com/view/fda-reviews-policies-on-off-label-promotion-and-online-advertising
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60
https://www.everycrsreport.com/reports/R40458.html
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61
https://www.venable.com/insights/publications/2018/03/offlabel-cases-arent-going-away-doj-sheds-light-o
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62
https://www.goodrx.com/healthcare-access/medication-education/off-label-drug-prescriptions
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63
https://millennialeye.com/articles/2021-jan-feb/understanding-on-label-off-label-and-unapproved-products/
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https://scholarlycommons.law.wlu.edu/cgi/viewcontent.cgi?article=4593&context=wlulr
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65
https://haiweb.org/media-resource/regulating-off-label-use-of-medicines-in-europe/
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66
https://www.kslaw.com/attachments/000/008/751/original/Pharmaceutical_Advertising.pdf?1619456143
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67
https://www.faegredrinkeronproducts.com/category/off-label-marketing/
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68
https://www.morganlewis.com/-/media/files/publication/outside-publication/article/berman_jhcc-1stamendmentofflabelpromotioncases_march2012.pdf
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69
https://medshadow.org/fda-needs-stand-off-label-marketing-efforts/
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70
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2720754
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71
https://www.nber.org/sites/default/files/2022-09/WhitePaperKao2_2017.pdf
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72
https://www.uspharmacist.com/article/free-speech-drug-marketing-and-off-label-use
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73
https://readingroom.law.gsu.edu/cgi/viewcontent.cgi?article=3601&context=faculty_pub
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74
https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5bf882928&appId=PPGMS
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75
https://www.slideshare.net/phillycooke/raps-2014-intended-use-and-on-label
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76
https://www.raps.org/news-and-articles/news-articles/2018/5/off-label-promotion-are-fdas-rules-about-to-unra
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77
https://rtp.fedsoc.org/paper/fdas-approach-off-label-communications-restricting-free-speech-medicine/
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78
https://www.foxrothschild.com/publications/fda%E2%80%99s-new-off-label-guidance-what-it-says-and-what-it-leaves-unanswered
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79
https://www.mddionline.com/news/how-avoid-label-device-promotion
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https://www.ecri.org/components/HRC/Pages/LawReg17.aspx?PF=1&source=print
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81
https://www.druganddevicelawblog.com/2012/12/caronia-off-label-promotion-and-firs.html
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82
https://www.policymed.com/2015/05/amarin-v-fda-off-label-first-amendment.html
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https://www.duanemorris.com/articles/static/ballduffyrussakoff_bender0409.pdf
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https://portal.research.lu.se/files/1345635/8569071.pdf
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85
https://repository.law.uic.edu/cgi/viewcontent.cgi?article=2839&context=lawreview
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86
https://learn.marsdd.com/article/unlicensed-healthcare-products-no-advertising-or-promotion-allowed/
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https://www.nixonpeabody.com/-/media/Files/Alerts/142219_FDA_Health_Alert_01_26_2012.ashx
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https://abc30.com/shopping/off-label-drug-use-ads/1763045/
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89
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3035413
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90
https://www.vsg-law.com/blog/off-label-promotions-and-prescriptions-pursued-under-the-false-claims-act/
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91
https://journals.sagepub.com/doi/10.1177/2631309X20970477
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92
https://www.efpia.eu/media/25016/promotion-of-off-label-use-of-medicines-by-european-healthcare-bodies-in-indications-where-authorised-medicines-are-available-november-2011.pdf
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93
https://www.insideeulifesciences.com/2021/07/06/new-early-access-and-off-label-use-rules-in-france/
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94
https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2017/09/26/will-arizonas-off-label-drug-law-spur-changes-elsewhere
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95
http://texaslawreview.org/wp-content/uploads/2015/08/McKenney.pdf
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https://www.quinnemanuel.com/the-firm/publications/article-january-2019-off-label-promotion-after-caronia-proceed-with-caution/
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