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Category Archives: FDA
Genentech Runs Voluntary Corrective Ads for Boniva
Even though Roche-owned Genentech wasn’t required to run costly corrective advertisements following an FDA Untitled Letter on Boniva last January, the company has done so anyway.
Also posted in Advertising, Corporate Responsibility, Legal, Marketing, Regulatory, compliance, leadership Tagged DDMAC, Genentech, OPDP, Roche Leave a comment
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, Legal, Marketing, Regulatory, Technology, compliance, social media Tagged FDA Leave a comment
Putting the M Back in M&A
Joe Panetta, president and CEO of BIOCOM, discusses an emerging model of M&As in which human and IP assets are valued and biotech brings expertise to Big Pharma as venture capitalist funding dwindles and patent cliffs loom large.
Pharm Exec: Can you tell me about how small biotech and specialty companies have started switching from relying [...]
Also posted in Agency Insight, Biotech, Deals Tagged BIOCOM, Joe Panetta, M&A, venture capital Leave a comment
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, Legal, Marketing, Regulatory, Strategy, patient education Tagged facts box 1 Comment
Unmet Need in the Migraine Space?