Dale Cooke is the Vice President/Group Director, Regulatory Review for Digitas Health LifeBrands and the author of the Food & Drug Law Institute's Effective Review and Approval of Digital Promotional Tactics.
- FDA Helping Pharma Operationalize Social Media in
Marketing: Health on
04/11/2014
Last year, I wrote in a Marketing:Health column, "The primary challenges for makers of prescription products with adopting social media are operational." I emphasized three sets of challenges: adverse
event reporting, responsiveness, and FDA filing requirements.
- Overcoming Social Media's Challenges in
Marketing: Health on
08/09/2013
The primary challenges with adopting social media for makers of prescription products are operational. Though much is made of the absence of an explicit Food and Drug Administration guidance on social
media, we know the answer to most of the questions about the regulatory requirements for social media activity.
- Digital Media Isn't' Risky, If Used Compliantly in
Marketing: Health on
03/04/2013
In the pharmaceutical industry, we have become accustomed to a discussion about adopting "risky" communications channels such as social media. These discussions overlook one thing: There are no risky
media.
- The FDA Social Media Guidance: The Path Forward in
Marketing: Health on
02/10/2012
In December, the FDA released the first of its long-awaited social media guidances. The collective response from industry was a shoulder shrug. So, where do we go from here?