Tag Archives: warning letters

Imaginary patients, Imaginary data, et Cetero, et Cetero…

Posted on 28 July 2011 by Ask-Cato.com Contributor

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet … Continue reading →

Posted in Clinical Trials, FDA, Industry News | Tagged , , , , , , , , , , , , , , , , , , , , , , , , | Comments Off

Conference Recap – 2011 ACRP Global Conference and Exhibition

Posted on 26 May 2011 by Ask-Cato.com Contributor

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals. Continue reading →

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What everyone should know about responding to Warning Letters.

Posted on 26 May 2010 by Ask-Cato.com Contributor

It takes less time to do something right than it takes to explain why you did it wrong. -Lee’s Law Interestingly enough, many people do not take advantage of the Warning Letters posted on the FDA website.  Personally, I always … Continue reading →

Posted in FDA | Tagged , , , | 1 Comment

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

Posted on 18 May 2010 by Leo DiNapoli

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 … Continue reading →

Posted in eCTD, Industry News | Tagged , , , , , , , , , | 1 Comment

DDMAC Sends Warning Letter Over Unbranded Websites

Posted on 17 May 2010 by Leo DiNapoli

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” … Continue reading →

Posted in FDA, Industry News | Tagged , , , , , , , , , , , , , | 2 Comments