FDA Guidance for Use of Social Media by Regulated Industries

While the FDA has only published draft guidance documents, they do reflect the agency’s current thinking.

There were three (3) draft guidance documents issued in 2014 by FDA to guide industry in the use of social media. The third was replaced in 2024 by the draft guidance, Addressing Misinformation About Medical Devices & Prescription Drugs – Questions and Answers – Guidance for Industry – July 2024. We will cover all three current draft guidances and provide insight as to how to interpret and implement them. These guidance documents will help you navigate the use of social media to ensure compliance.

The guidance documents relate to content, format and liability. It is important to know under what circumstances a company is responsible for social media posts about its branded products. We will also cover the role of “influencers” and how FDA is studying how these impact consumers.

Description:

The first two draft guidance documents are:

1. Fulfilling Regulatory Requirements for Post-marketing Submissions of Interactive Promotional Media for Prescription Human & Animal Drugs & Biologics – January 2014
2. Internet/Social Media Platforms with Character Space Limitations – Presenting Risk & Benefit Information for Prescription Drugs & Medical Devices – June 2014

The third draft guidance document is:

3. Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs & Medical Devices – June 2014

The third draft guidance was replace in July 2024 by the new draft guidance, Addressing Misinformation About Medical Devices & Prescription Drugs – Questions and Answers – Guidance for Industry – July 2024.

This replacement draft guidance from FDA will be discussed, as it differs from the third draft. This draft will replace the third draft guidance listed above.

We will also take a look at social media regulations from various areas of the world, where countries have implemented guidelines and requirements similar to those by FDA in the US. Finally, we’ll discuss the role of the Federal Trade Commission (FTC), as it continues working with FDA to fine-tune regulations.

Why Should You Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, tobacco and tobacco-related (e-liquid, cigars). Functions that are applicable include marketing, regulatory affairs, compliance, sales, manufacturing, Quality Control, clinical study management, labeling, adverse events management, and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the processes related to using social media to post or monitor product-related information.

Areas Covered in the Webinar:

This webinar will cover the following key areas:

• Pros and cons of using social media venues

• Compliant use of Social Media in an FDA-regulated Environment

• FDA draft guidance documents

• Balancing benefit and risk information on social media posts

• Managing character space limitations on social media posts

• Managing misinformation posted by independent third-parties

• Pending regulatory action by the US Congress
• Q&A

Who Will Benefit:

Personnel in the following roles will benefit:

• Website Administrators
• Legal
• Marketing
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid and other FDA-regulated industries.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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