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Blog Posts for Tag: FDA

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Posted by Mike Nickel on August 12, 2010 at 10:51 am | 195 Views | 0 Comments

On July 29, 2010, the FDA issued a warning letter to Novartis stating that content shared through Facebook and ShareThis functionality "... is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products."

Tags: FDA, regulatory, warning letter, social media, Facebook

Posted by Barbara Lavery on November 20, 2009 at 2:53 pm | 2303 Views | 0 Comments

First of all, I am President of a healthcare interactive agency engaged in both online DTC and DTP marketing – just to get that out of the way. I attended the FDA Internet and Social Media hearings and I have a few thoughts that have been bothering me ever since. The hearings suffered from a tendency on the part of speakers to repeat the same thing over and over again, I suppose in the hopes that the FDA would just believe it if they heard it often enough. A few of these repeated assumptions included:

Tags: DTC, FDA , pharmaceutical Internet marketing, DDMAC, e-patients, online health

Posted by Barbara Lavery on November 13, 2009 at 6:09 am | 2583 Views | 1 Comments

Day One included 10 minute presentations and statements by over a dozen agencies, 3 pharmaceutical companies (J&J, Sanofi Aventis, and Eli Lilly & Company) and the Internet heavy hitters including Wayne Gatinella, WebMD, David Zinman from Yahoo, Mary Anne Belliveau and Amy Cowan from Google and a nicely done data dump on Internet usage by physicians and online health information seekers from Mark Bard at Manhattan Research.

There was also a heavy helping of PhRMA and IAB waffling that seemed to say “we recognize the need for ideas, we just don’t have any right now…” but I admit to being a little bitter due to the enormous line for coffee and once I got some the “rules” not allowing any in the meeting room…

Tags: FDA, DDMAC, pharmaceuticals, DTC, social media, marketing

Posted by Barbara Lavery on September 25, 2009 at 3:36 am | 1590 Views | 0 Comments

FDA (CDER CBER CVM AND CDRH) has announced a public hearing to discuss issues around promotion of FDA-regulated medical products including prescription drugs, biologics, and medical devices using the Internet and social media tools. Participation by industry, patients, caregivers, HCPs is critical if the resulting regulations are to make sense...

Tags: social media, FDA, DDMAC

Posted by Barbara Lavery on February 2, 2009 at 1:07 pm | 2367 Views | 1 Comments

Don't plan a trip to the Waldorf Astoria next week unless you are into healthcare and biotech or have a penchant for fighting your way through a sea of bankers and anxious CEOs. Both the UBS Healthcare Services conference and the annual BIO CEO meeting will descend on New York on Sunday 8th through mid-week.

Tags: Investor Strategies, UBS Healthcare, BIO CEO New York Conference, Obama Healthcare, FDA Commissioner


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