This seminar is intended to help you adequately implement good social media practices to avoid FDA enforcement actions for potential misbranding of your prescription drugs (humans and animals), biologics, and medical devices including other healthcare products (dietary supplements, cosmetics and OTCs).
On June 27, 2014, FDA issued an untitled letter to a pharmaceutical company concerning the firm’s sponsored link on the internet search engine. FDA states:
"The sponsored link provides evidence that the drug is intended for a new use for which it lacks approval, and for which its labeling does not provide adequate directions for use, which renders the drug misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or otherwise makes its distribution violative."
The U.S. Food and Drug Administration (FDA) reviewed the firm’s sponsored link on the Google as part of the FDA’s routine monitoring and surveillance program by the Office of Prescription Drug Promotion (OPDP). It is imperative that firms ensure their compliance to the applicable laws and regulations when they provide drug or device information to the public through social media.
In this presentation, the speaker will discuss what to consider and how to establish your good social media practices while ensuring your compliance to the laws and regulation to avoid potential FDA enforcement actions.
This 60 min seminar presentation will provide you a great opportunity to understand FDA’s perspective on social media practices covered in FDA’s recent guidances. You will learn about the various considerations that pharmaceutical and medical device firms need to consider when establishing procedures for social media practices.
- Applicable Laws and Regulations
- FDA’s Current Thinking and Perspectives
- FDA’s Three (3) Social Media Guidances Issued in December, 2011 and June, 2014
- Best Social Media Practices
- FDA Enforcements: Recent Cases
- Advertising and Promotion on Social Media - Twitter, Facebook, YouTube, WordPress and Blogger
- PASS-IT Recommendations: Dos and Don'ts.
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
- R&D Scientists, Managers, Directors, and VPs
- Regulatory Affairs and Compliance Professionals
- Clinical Affairs Professionals
- Quality Professionals
- Legal and Compliance Officers
- Marketing Professionals
- Senior Management
- Anyone Interested in the Subject.