Fwd: FDA off-label promotion

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What's the difference between legal and illegal promotion of off-label uses?

Many drug and device companies don't know the right answer.

Miscues with off-label promotion are nearly always the result of weak (or nonexistent) training that assures it's only a matter of time until a promising promotion strategy turns in to a legal nightmare – a nightmare that can result in fines, criminal penalties and liability lawsuits involving millions, even billions of dollars.

Here's what you need to know NOW to avoid a call from the FDA's Office of Criminal Investigations about an off-label violation.

An FDAnews Management ReportDrug and Device Off-Label PromotionStrategies for Regulatory Compliance and Minimizing Liability

This report is the clearest and most practical training available today for avoiding problems with off-label promotion.

Step-by-step, in plain English, it tells what drug- and device-makers must do to navigate between legal and illegal dissemination of off-label use information ... and minimize product liability concerns.

Buy now to arm your marketing team, sales reps, training staff and others with the knowledge they need to promote your products — without the risk of off-label violations. Specifically, with this guide, you'll learn:

How off-label promotion is defined — and the regulations and penalties that are associated with noncompliance Real-world examples of "implicit off-label marketing traps" and how to spot and avoid similar traps in your own promotions What constitutes allowable vs. unallowable communications used to discuss off-label product uses Best practices for minimizing the risk of off-label promotion violations Tips on creating an effective off-label promotion compliance program and training And more

Buy NowDrug and Device Off-Label Promotion: Strategies for Regulatory Compliance and Minimizing Liability is offered by FDAnews in print or online in PDF format for $377.Act now: place your order here. (Add $10 shipping and handling for printed reports shipped to the U.S. and Canada, or $35 per report shipped elsewhere. Virginia residents, please add 5 percent sales tax.)

Satisfaction GuaranteedYour purchase is 100% guaranteed. If for any reason you decide the report is not for you, simply return the undamaged hard copy within 30 days of purchase and you'll receive a full refund (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.

Four Easy Ways to OrderPlease mention priority code 11O24 when ordering.

Order online. Call toll free (inside the U.S.) or +1 . Use your American Express, Visa or MasterCard. Fax your purchase order to +1 .

Mail your check to: FDAnews, 300 N. Washington St., Suite 200Falls Church, VA 22046-3431.

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