cGMPs

Complying with the FDA’s Draft Guidance on Social Media

By Dose of Digital

Five key takeaways from the FDA's Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, courtesy of Dose of Digital:

1) Balance all claims made on owned property

2) Brands are only responsible for content that they produce

3) When it comes to third party blogger engagements, the firm is not responsible for the information on a third-party site and has no obligation to submit to the FDA

4) Transparency of brand affiliation

5) FDA submissions of real time interactions don't have to be submitted prior to deployment (a brand can respond to social media posts without pre-clearing with FDA)

Read the Dose of Digital blog post here

Free Subscriptions

Pharma Manufacturing Digital Edition

Access the entire print issue on-line and be notified each month via e-mail when your new issue is ready for you. Subscribe Today.

pharmamanufacturing.com E-Newsletters

A mix of feature articles and current new stories that are critical to staying up-to-date on the industry, delivered to your inbox. Choose from an assortment of different topics and frequencies. Subscribe Today.