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Social Media Guidances FDA is expected to have the following guidances:
Responding to unsolicited requests Fulfilling regulatory requirements when using tools associated with space limitations Fulfilling post-marketing submission requirements Online communications for which manufacturers, packers, or distributors are accountable Use of links on the Internet
Page 1 and 2:
Darshan Kulkarni, Pharm.D, MS, Esq.
Page 3 and 4:
Pharm.D JD MS in QA/RA
Page 5 and 6:
Compliance Legal Regulatory
Page 7 and 8:
What are 3 elements you want in you
Page 9 and 10:
What is this presentation NOT about
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What is this presentation NOT about
Page 13 and 14:
Participating in Social Media Pros
Page 15 and 16: Pros • It is instantaneous.
Page 17 and 18: Cons • Once something is out ther
Page 19 and 20: Cons • If I don’t know about it
Page 21 and 22: Cons • Inadequate Guidance
Page 23 and 24: Code of Conduct Sexual Harassment P
Page 25 and 26: • DMCA Concerns •Have take down
Page 27 and 28: Decide which sites you will “adop
Page 29 and 30: You are the brand manager for a dru
Page 33: Social Media Don'ts Using parent/su
Page 37 and 38: Promotions Recap
Page 39 and 40: Types of DTC Ads • Help Seeking A
Page 41 and 42: Types of DTC Ads Product Claim Ad
Page 43 and 44: Current State • Distinguish betwe
Page 45 and 46: Current State • Astra Zeneca: Twi
Page 47 and 48: • The "Invisibility Rule" does no
Page 49 and 50: Enforcement Actions Trending
Page 51 and 52: What Should You Do? You are the bra
Page 53 and 54: Enforcement Actions
Page 55 and 56: Good Promotion Practices
Page 58 and 59: Good Pharma Social Media Promotion
Page 60 and 61: Good Pharma Social Media Promotion
Page 62 and 63: Monitor Use Third Parties to evalua
Page 64 and 65: Your SM Policy What are 3 elements
Page 69 and 70: Future of Social Media • DDMAC is
Page 71 and 72: ... but we don’t have all the SM
Page 73 and 74: Questions? @FDALawyers Join us to c
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