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A Guide to FDA and FTC Enforcement management report

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FALLS CHURCH, Va. (PRWEB)

Risks of Social Media Communication:

A Guide to FDA and FTC Enforcement

https://www.fdanews.com/products/62851

Drug and devicemakers need to ensure their social media communications are reaching consumers and not encouraging enforcement action by the FDA and FTC. Risks of Social Media Communication: A Guide to FDA and FTC Enforcement will show manufacturers how to make sure their social media messages promote, rather than hurt them.

With both agencies focusing more on their use of social media, and accelerated enforcement action for related promotional violations, manufacturers can’t afford to go without this clarification of what can be extremely complicated areas.

Drawing on a recent FDAnews webinar featuring two Ropes & Gray partners deeply engaged in health science regulatory issues and challenges, Risks of Social Media Communication will enable readers to navigate the gray areas and manage risk so they can optimize direct-to-consumer engagement without triggering enforcement action.

This report explains how to proceed with social media communications in a compliant way, providing critical information about the enforcement landscape. It clarifies the FDA and FTC regulations that affect the use of social media, how the agencies are currently enforcing their regulations and includes key FDA guidance and details from recent warning and untitled letters.

And it will show practical considerations that must accompany social media use, including a set of best practices and tips on specific steps to take to ensure compliance, including:

  • Details from recent Office of Prescription Drug Promotion (OPDP) warning and untitled letters that illustrate how the existing regulations are applied in practice to drugmakers’ social media activity

  • Exactly when the FDA or FTC considers online or social media content to be attributable to a product manufacturer, including noncompany personnel who may still have ties to the product manufacturer

  • How to make the best use of patient and healthcare provider testimonials, and when regulators may consider such statements to be the same as if the company itself made them

  • How to distinguish between promotional and nonpromotional communications on social media as well as the legal requirements and special considerations that apply to each, such as content, tone and disclaimers

  • How to use consumer-friendly language to present information, including safety and risk considerations, across a variety of social media platforms

  • Key considerations for applying a risk-based approach to managing online and social media communication risks, such as product novelty, the frequency of information provided and monitoring of user-generated content, among other factors

If drug and devicemakers want to fully take advantage of direct-to-consumer social media, and stay compliant, they’ll need Risks of Social Media Communication: A Guide to FDA and FTC Enforcement.

Management Report Details

Risks of Social Media Communication:

A Guide to FDA and FTC Enforcement

https://www.fdanews.com/products/62851

Price:

$397

Easy Ways to Order:

Online: https://www.fdanews.com/products/62851

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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