FDA Guidance for Use of Social Media by Regulated Industries

Overview:

In the early days of social media, regulatory agencies were observers — watching as pharmaceutical and medical device companies experimented with platforms like Twitter, YouTube, and Facebook to engage with healthcare professionals and consumers. Over time, as digital engagement became standard practice, the FDA recognized the need to provide guardrails that could help industry navigate this dynamic environment without compromising public health or regulatory integrity.

In 2014, the FDA issued three core guidance documents designed to clarify expectations around promotional practices on social media. These addressed key areas such as character space limitations, post-marketing submission requirements, and the correction of misinformation from independent third parties. These documents provided much-needed clarity at the time, but the pace of change in the digital ecosystem has outstripped the static nature of those guidances. As technology advanced — and as social media evolved into a multi-platform ecosystem with influencers, short-form video, real-time conversations, and algorithm-driven visibility — new challenges emerged.

Recognizing the limitations of the earlier guidance, the FDA released a fourth document in July 2024: a draft guidance intended to replace and expand upon its previous recommendations related to third-party misinformation. This document marks a notable evolution in the agency’s thinking — not only clarifying how companies may respond to inaccuracies online but also reflecting a deeper awareness of how digital content influences consumer decisions, clinical expectations, and brand perception. With this new draft guidance, the FDA is signaling that companies must not only monitor their own communications but also understand when, why, and how they might be held responsible for what others say about their products.

This webinar will provide attendees with a clear and detailed roadmap of all four guidance documents — explaining what remains consistent, what has changed, and what it all means for day-to-day compliance. Topics will include how to maintain benefit-risk balance in constrained formats (like tweets or Google ads), what qualifies as a corrective communication, how to manage post-marketing submissions when engaging on interactive platforms, and what responsibilities companies bear for content shared by affiliates, influencers, or even patients.

We’ll also touch on the global picture. Regulatory agencies in Europe, Asia, and South America are increasingly issuing their own social media frameworks, some inspired by FDA policy, others diverging in key ways. Understanding these trends is vital for multinational organizations managing product promotion across markets. Additionally, we’ll explore the role of the U.S. Federal Trade Commission (FTC), which has become increasingly active in shaping how product endorsements and digital advertising are handled online, especially with regard to transparency and disclosure.

The landscape in 2025 demands a more proactive and informed approach to digital communication. This session will provide the historical background, regulatory interpretation, and real-world context you need to build compliant, responsive, and future-ready social media strategies for FDA-regulated products.

Areas covered in the session:

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
• Managing character space limitations on social media
• Managing misinformation posted by independent third-parties
• Pending regulatory action by the US Congress
• Q&A

Why should you attend?

Social media may feel familiar, but when it comes to FDA-regulated products, the rules behind what can be posted — and who is responsible — are anything but simple. This session will help you move beyond general marketing instincts and into the regulatory mindset that governs digital communication in the drug and device industries.

With multiple FDA guidance documents — including the latest draft issued in 2024 — there’s growing pressure on companies to not only comply with what’s written, but also to interpret evolving expectations around misinformation, influencer marketing, and post-marketing submissions. If you’ve struggled to connect policy to practice, this session will help bridge that gap with real-world clarity.

Whether you’re involved in compliance, regulatory affairs, digital marketing, or legal review, this webinar will give you a structured, current understanding of how to manage your online presence without risking enforcement. It’s not just about staying out of trouble — it’s about building communication strategies that are credible, compliant, and aligned with FDA expectations.

What industries will benefit from this training:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?

Personnel in the following roles will benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Marketing
• Legal
• Website Administrators
• 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

ABOUT PRESENTER:

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

NOTE FOR ATTENDEES:

Live attendees will receive a WebEx meeting invitation upon successfully completing the registration.

Please note that if you have registered two or more attendees, each participant will receive their own WebEx invitation from the organizer at a later time. The registered user will receive an email from the organizer requesting details for all other participants.

Participants who have opted for the recorded version of the program will receive a WebEx link within 8 hours after the event's completion. Using this link, participants can view or download the event at their convenience.