FDA Permitted Off-Label Promotion: The Regulatory Paradigm

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

FDA Permitted Off-Label Promotion: The Regulatory Paradigm

Many FDA approved products have uses beyond what they have been approved for. Manufacturers have to follow strict guidelines to inform physicians about these additional uses. Manufacturers also have to deal with consumers directly asking for more information about such uses.

Update yourself with all the FDA-acceptable practices to collect, distribute, and manage off-label information about FDA-approved products with our expert speaker Dr. Mukesh Kumar. You get practical advice based on multiple case studies regarding off-label promotion for products by the manufacturers.

Plus, you get a list of do’s and don’ts for discussing published material, clinical experience, investigational uses, and anecdotal information. Our expert will also discuss the Do's and don'ts of social media techniques in off-label promotion.

Here are a few highlights of the session:

  • FDA-permitted off-label promotion techniques
  • FDA guidance about off-label information management
  • What is an Off-Label Use?
  • Pros and cons of common methods for off-label promotion
  • Converting off-label to on-label information
  • Do’s and don’ts of social media techniques in off-label promotion
  • Legal Vs Regulatory Paradigms
  • Commercial Promotion of Off-Label Use
  • Common Myth: FDA Does not Allow Off-Label Use
  • Regulation of Advertisement
  • Request for Off-Label Information
  • Do’s and Don’ts for Responding to Unsolicited Request
  • Risks with Soliciting information
  • Distributing Peer-Reviewed Published Literature
  • Common Complaints from FDA
  • What to Expect in the Near Future
  • And much more…

Who should attend?

  • Manufacturers of FDA regulated products: Drug, medical devices,  biotech companies and dietary supplement manufacturers
  • Marketing and advertising professionals
  • Financial analysts, investors, venture capitalists, and insurance professionals
  • Legal experts involved in advising manufacturers of marketed products
  • Senior management for companies developing new products for US market
  • Regulatory affairs professionals, research analysts

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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