As 2011 came to a close, the U.S. Food and Drug Administration released draft guidance on responding to unsolicited requests for off-label information, which included guidance on how to respond to requests made online. The draft guidance reiterates past guidance and compels pharmaceutical and medical device companies to adhere to existing federal regulations…
Tag Archives: FDA
FDA Talks Social with Off-Label Guidelines
January 9, 2012
Health Digital Check-Up: Health Activists Ask for Company Involvement in Social Media
May 24, 2011
This just in… we’re still waiting for guidance from the FDA on social media. Actually, we AREN’T waiting. We can’t afford to wait. The fact is, the social media train has left the station, and we at Edelman have been actively working with our clients in the regulated space to help them navigate the medium without official guidance.
To add more fuel to the fire, WEGO Health has updated their original survey of their Health Activists (
Health Digital Check-Up: What’s Going on at the FDA
September 7, 2010
Despite the Internet being around for quite some time, the FDA has never issued specific guidance to pharmaceutical companies on how they can communicate about and market their products online, instead stating that the existing guidelines for print and television should be applied. However, there is difficulty in interpretation: if providing the prescribing information on the back of a print ad is acceptable, is that equal to having the information one click away? Instead of official guidance and directives, we learn what is okay – and what doesn’t fly – through…
Health Digital Check-Up: The FDA Warns About Facebook Share
August 10, 2010
As we wait for the official word from the FDA on how the DDMAC guidelines should be applied to the digital space, we can learn how the FDA is interpreting the use of social media for promotional activities through their warning letters. Novartis Pharmaceuticals Corporation (an Edelman client, though not for this particular promotion) recently received a warning letter…
Health Digital Check-Up: The Breakdown on Unbranded Sites
August 3, 2010
While the ambiguous regulatory environment has generally stymied online communications for the healthcare industry, unbranded disease education websites have provided an opportunity to maximize reach, engagement and innovation of online initiatives without contravening existing FDA regulations.
As evidenced by recent warning letters issued to pharmaceutical companies about unbranded websites, in the eyes of DDMAC, the distinction between branded and unbranded is…
Health Digital Check-Up: A Little Light Reading
July 27, 2010
It seemed helpful the first time the Check-Up doubled as a book club, so to continue the link sharing, here are another five resources to check out when you are looking for news in the digital health space.
Newsmap
There is never enough time in the day to keep up with trends and news. However, sometimes tracking down the big story is worth your time, and luckily there’s a really cool…
