Did you know the FDA recently issued a multi-million dollar contract to a private company that will be charged with monitoring social media? Yes, multi-million. Needless to say, that’s a significant amount of money.
Although many would argue the FDA has not been very clear regarding its guidance towards social media, you can’t deny that the FDA is beginning to take social media more serious than it ever has.
In this interview with Dr. Mukesh Kumar, Senior Director of Regulatory Affairs for Amarex Clinical Research, we’ll discuss common issues, misconceptions, and possible solutions in regards to using social media to market and sell FDA-regulated medical devices.
Interview Highlights with Dr. Mukesh Kumar
- Why one particular company received a warning letter from the FDA for clicking the Facebook “Like” button.
- Trends and recent discussions regarding the FDA’s overview and enforcement of social media as it pertains to marketing medical devices.
- Risks and benefits: FDA guidance documents regarding the distribution of information via social media.
- Best practices for managing social media within the medical device space.
- If a patient submits a question regarding a medical device via Twitter, how is it possible to present balanced information given the 140-character limit?
- If unidentified patients post comments regarding adverse events on a website not controlled by the medical device company, is that company required to report the event to FDA or attempt to contact the patient?
Dr. Mukesh Kumar is the Senior Director of Regulatory Affairs and Quality Assurance for Amarex Clinical Research. His key expertise is in global regulatory and business processes for medicinal and diagnostic products. Dr. Kumar serves on the Board of Editors for the Regulatory Affairs Professionals Society (RAPS). He is also the President of the Global Alliance of Indian Biomedical Professionals. Dr. Kumar holds a PhD in Biochemistry with specializations in virology, gene therapy, and molecular biology. He has worked as a research scientist at the NIH, Baylor College of Medicine in Houston, and premier institutions throughout India.
Did you know the FDA recently issued a multi-million dollar contract to a private company that will be charged with monitoring social media? Yes, multi-million. Needless to say, that’s a significant amount of money.
Although many would argue the FDA has not been very clear regarding its guidance towards social media, you can’t deny that the FDA is beginning to take social media more serious than it ever has.
In this interview with Dr. Mukesh Kumar, Senior Director of Regulatory Affairs for Amarex Clinical Research, we’ll discuss common issues, misconceptions, and possible solutions in regards to using social media to market and sell FDA-regulated medical devices.
Interview Highlights with Dr. Mukesh Kumar
- Why one particular company received a warning letter from the FDA for clicking the Facebook “Like” button.
- Trends and recent discussions regarding the FDA’s overview and enforcement of social media as it pertains to marketing medical devices.
- Risks and benefits: FDA guidance documents regarding the distribution of information via social media.
- Best practices for managing social media within the medical device space.
- If a patient submits a question regarding a medical device via Twitter, how is it possible to present balanced information given the 140-character limit?
- If unidentified patients post comments regarding adverse events on a website not controlled by the medical device company, is that company required to report the event to FDA or attempt to contact the patient?
Dr. Mukesh Kumar is the Senior Director of Regulatory Affairs and Quality Assurance for Amarex Clinical Research. His key expertise is in global regulatory and business processes for medicinal and diagnostic products. Dr. Kumar serves on the Board of Editors for the Regulatory Affairs Professionals Society (RAPS). He is also the President of the Global Alliance of Indian Biomedical Professionals. Dr. Kumar holds a PhD in Biochemistry with specializations in virology, gene therapy, and molecular biology. He has worked as a research scientist at the NIH, Baylor College of Medicine in Houston, and premier institutions throughout India.
