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DTSTART:19700308T020000
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UID:2140535:Event:68731
DTSTAMP:20260522T105813Z
SUMMARY:Webinar on FDA Off-Label Promotion Guidelines
DESCRIPTION:Description :\nMany FDA approved products have uses beyond
  what they have been approved for. Manufacturers have to follow very s
 trict guidelines to inform physicians about these additional uses. Man
 ufacturers also have to deal with consumers directly asking for more i
 nformation about such uses. This seminar will discuss FDA-acceptable p
 ractices to collect, distribute and manage off-label information about
  FDA-approved products.\nPractical advice based on multiple case studi
 es regarding off-label promotion for products by manufacturers. Attend
 ees will get a list of do’s and don’ts for discussing published ma
 terial, clinical experience, investigational uses, and anecdotal infor
 mation. Social media techniques will also be discussed.\nAreas Covered
  in the Session :\nFDA-permitted off-label promotion techniques\nFDA g
 uidance about off-label information management\nWhat is an Off-Label U
 se?\nPros and cons of common methods for off-label promotion\nConverti
 ng off-label to on-label information\nDo’s and don’ts of social me
 dia techniques in off-label promotion\nLegal Vs Regulatory Paradigms\n
 Commercial Promotion of Off-Label Use\nCommon Myth: FDA Does not Allow
  Off-Label Use\nRegulation of Advertisement\nRequest for Off-Label Inf
 ormation\nDo’s and Don’ts for Responding to Unsolicited Request\nR
 isks with Soliciting information\nDistributing Peer-Reviewed Published
  Literature\nCommon Complaints from FDA\nWhat to Expect in the Near Fu
 ture\nSpeaker’s Recommendation and Suggestions on PASS-IT Solutions\
 nConclusion\nWho Will Benefit:\nManufacturers of FDA regulated product
 s: Drug, Medical Device and Biotech Companies, Dietary supplement manu
 facturers\nMarketing and Advertising Professionals\nFinancial analysts
  and investors, venture capitalists, insurance professionals\nLegal ex
 perts involved in advising manufacturers of marketed products\nSenior 
 management for companies developing new products for US market\nRegula
 tory affairs professionals, research analysts\n\nFor more information 
 visit https://medtechiq.ning.com/events/webinar-on-fda-off-label-promo
 tion-guidelines
DTSTART;TZID=America/New_York:20160406T130000
DTEND;TZID=America/New_York:20160406T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1783
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1783
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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