Tag Archive: DDMAC

Aug 11 2010

Accelerated Approval

Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics:  What is accelerated approval and how does it work? The process is defined in 21 …

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May 18 2010

Bad Ads – FDA Recruits Health Care Providers to Combat Misleading Advertising

If your advertising goes unnoticed, everything else is academic. – William Bernbach Fierce reported that the “FDA has issued 186 warning letters so far this year”.  (Looking at that number, they must mean “warning and untitled letters” which are frequently conflated). Assuming that 1) this covers January through April only and 2) this pace continues, …

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May 17 2010

DDMAC Sends Warning Letter Over Unbranded Websites

If you judge, investigate. – Seneca I know you just read the title, but let me say it again with some emphasis:  DDMAC Sends Warning Letter Over Unbranded Websites.  That’s right, a warning letter over websites that contained no “direct” references to a product…although, as we’ll see, the indirect references were too direct for the …

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Apr 22 2010

First Example of Proposed DTC Rules in Effect?

No one can possibly know what is about to happen: it is happening, each time, for the first time, for the only time. – James Arthur Baldwin Hey, remember those proposed DTC advertising rules that the FDA published recently?  Well, we may be getting a preview of a world where those rules are in effect. …

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Apr 08 2010

FDA Proposes New Direct-to-Consumer (DTC) Advertising Rules

Good advertising does not just circulate information.  It penetrates the public mind with desires and belief. – Leo Burnett The FDA recently published a proposed rule for how risk information should be presented in Direct-to-Consumer (DTC) advertising.  Per FDAAA 2007, the FDA was mandated to ensure that the description of side effects and contraindications (the …

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