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Category Archives: Regulatory
Off-Label Comments Online: Keep Doing What You're Doing, Says FDA
Those in favor of a less is more approach to FDA social media guidelines got what they wanted for the holidays: a trim, 15-page document on how to respond to unsolicited off-label comments
Also posted in Advertising, E-Media, FDA, Legal, Marketing, Technology, compliance, social media Tagged FDA Leave a comment
The 'S' Word in Healthcare Reform
by Tom Norton
In little more than two years, the main elements of the HCR will take hold across the nation. As implementation continues to ramp up, one of the more intriguing questions surrounding its activation is, is the “S” word being realized?…That is, “S” as in “savings.” Are the much publicized “savings” that were projected [...]
Also posted in Guest Blog, Strategy, healthcare Tagged ACO, CLASS Act, healthcare costs, healthcare reform, HHS, Medicare Advantage 3 Comments
Why the Delay on Facts Boxes?
Despite a near-complete absence of criticism coming from industry, academia, clinicians and patients, the drug facts box – a concise, quantitative, easy-to-read format for presenting a drug’s risk/benefit profile in print advertisements – seems at least three years away from launch.
Also posted in Advertising, FDA, Legal, Marketing, Strategy, patient education Tagged facts box 1 Comment
Accelerated Approvals Could Raise Risks for Patients
By Erik Greb.
FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower [...]
Also posted in Guest Blog, Safety Tagged approvals, Avandia, Chantrix, fast-track, FDA Leave a comment
Genentech Runs Voluntary Corrective Ads for Boniva