communicating and marketing your product or technology in today’s healthcare environment
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Communicating and Marketing Your Product or Technology in Today’s Healthcare Environment Resources Joni Bradley, PharmD, @ JB_Ashtin , [email protected] , Session Moderator. PANELIST’S CONTACT INFO. RESOURCES. Policy and Medicine (great general resource): http://www.policymed.com / - PowerPoint PPT PresentationTRANSCRIPT
Communicating and Marketing Your Product or Technology in
Today’s Healthcare EnvironmentResources
Joni Bradley, PharmD, @JB_Ashtin, [email protected],Session Moderator
JBASHTIN.COM
PANELIST’S CONTACT INFO
Lee M. Tumminello Partner, Health Care and FDA Group at
Faegre Baker Daniels, LLP
Katherine Norris, MPASenior Director, Compliance & Integrity
Programs at NSF Health
2
JBASHTIN.COM
RESOURCES• Policy and Medicine (great general resource): http://www.policymed.com/
• Office of Prescription Drug Promotion and related guidances• http://
www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm081617.htm
• Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices
• http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.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/UCM285145.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– Q/A on Draft Guidance– http://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
• Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff• http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf 3