Monthly Archives: August 2010

What Type Meeting Are You? A B or C?

 This post is both interesting and boring at the same time.  Sorry about that. I read, however, a release by a company about its product under development that stated in the headline that the company was seeking a "Type B" … Continue reading

Posted in FDA Policy | 1 Comment

Roche Publishes Social Media Principles

 The wrestling match in the development of social media guidelines is not confined to the health care industry, but as a highly regulated sector, there are some serious considerations for companies vis a vis social media.  Direction is hard to … Continue reading

Posted in New and Social Media | 1 Comment

A Look at FDA’s Transparency

When Ed Koch was mayor of New York, he'd often ask a crowd "How am I doin?"  If you are in a position of authority, it isn't a bad question to ask every now and then, as long as you … Continue reading

Posted in FDA Policy | 2 Comments

More Warning and NOV Letters to Come?

Everyone has noticed the uptick in Warning Letters and NOV letters coming out of DDMAC these days and written about several times over the past year on this blog. In case you haven't, here is an updated chart where I … Continue reading

Posted in Warning Letters | 2 Comments

Tap, Tap, Tap … Waiting for an Alzheimer’s Test? A Spinal Tap Test Emerges.

 A headline that has been both craved and feared appeared yesterday:  "Spinal-Fluid Test is Found to Predict Alzheimer's" The New York Times reports that the Archives of Neurology is today publishing a study on a test for Alzheimer's that is … Continue reading

Posted in Current Affairs, Research | 1 Comment