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Communicating and Marketing Your Product or Technology in Today’s Healthcare Environment Resources Joni Bradley,

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Presentation on theme: "Communicating and Marketing Your Product or Technology in Today’s Healthcare Environment Resources Joni Bradley,"— Presentation transcript:

1 Communicating and Marketing Your Product or Technology in Today’s Healthcare Environment Resources Joni Bradley, PharmD, @JB_Ashtin, jbradley@jbashtin.com, Session Moderator jbradley@jbashtin.com

2 PANELIST’S CONTACT INFO Lee M. Tumminello Partner, Health Care and FDA Group at Faegre Baker Daniels, LLP Lee.Tumminello@FaegreBD.com Katherine Norris, MPA Senior Director, Compliance & Integrity Programs at NSF Health knorris@nsf.org JBASHTIN.COM 2

3 RESOURCES Policy and Medicine (great general resource): http://www.policymed.com/http://www.policymed.com/ Office of Prescription Drug Promotion and related guidances http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAd vertisingandCommunications/ucm081617.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAd vertisingandCommunications/ucm081617.htm Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM38 7652.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM38 7652.pdf Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM28 5145.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM28 5145.pdf – Q/A on Draft Guidance – http://www.agg.com/files/Publication/25e251ad-39a8-41c1-b181- 81611942d5e0/Presentation/PublicationAttachment/81801f2f-7f3c-4849-a587-0882821f1115/Minsk-Cohen- Asked-Answered-Now-Move-On%5B1%5D.pdf http://www.agg.com/files/Publication/25e251ad-39a8-41c1-b181- 81611942d5e0/Presentation/PublicationAttachment/81801f2f-7f3c-4849-a587-0882821f1115/Minsk-Cohen- Asked-Answered-Now-Move-On%5B1%5D.pdf Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf JBASHTIN.COM 3

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