Tag Archive: off label promotion

Feb 20

New FDA Guidances – December 2011/January 2012

Here’s a list of the notable guidances released by FDA in December 2011 and January 2012, compiled by Cato Research Regulatory Scientist Cathy Anderson. December 2011 FDA Portable Document Format (PDF) Specifications (Updated) (More info on this guidance can be found in this previous blog post) The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications …

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May 18

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

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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