Pathway's New World of Hurt
Finding the quickest pathway to a warning letter
Wednesday, September 28, 2011
Finding the quickest pathway to a warning letter
Wednesday, September 28, 2011
CU Bhind gym 2day 4real, LOL -FDA
Who says the federal government doesn't get new media?
Tuesday, July 19, 2011
Who says the federal government doesn't get new media?
Tuesday, July 19, 2011
Entertaining Diagnostics
I'll be honest, this one really got under my skin when it happened.
Monday, December 20, 2010
I'll be honest, this one really got under my skin when it happened.
Monday, December 20, 2010
BRCA1 And Me
We need this test held to high standards precisely because it is so important.
Thursday, October 21, 2010
We need this test held to high standards precisely because it is so important.
Thursday, October 21, 2010
Patent (Had Better Be) Pending
The days of using the term as an empty threat may be ending.
Monday, March 08, 2010
The days of using the term as an empty threat may be ending.
Monday, March 08, 2010
Four Eighty Threes, Three French Hens...
Hopefully you've never been issued a warning letter, so I'd like to walk you through what a typical one looks like.
Monday, December 21, 2009
Hopefully you've never been issued a warning letter, so I'd like to walk you through what a typical one looks like.
Monday, December 21, 2009
IVDMIA: No Longer MIA?
I'm sure I'll have more to say when we see the final guidance.
Friday, December 04, 2009
I'm sure I'll have more to say when we see the final guidance.
Friday, December 04, 2009
What is a "Regulatory Affair" and should I have one?
Perhaps we have more in common with a fiery mistress or hunky boy toy than we might suspect.
Monday, July 13, 2009
Perhaps we have more in common with a fiery mistress or hunky boy toy than we might suspect.
Monday, July 13, 2009
Making Progress by Crushing Dreams
Some dreams really need a good crushing in order for marketplace credibility to survive.
Thursday, May 28, 2009
Some dreams really need a good crushing in order for marketplace credibility to survive.
Thursday, May 28, 2009
A Statement of (Unreviewed) Beliefs
Sure, I got my information from a television commercial, but if you can’t believe television, what can you believe?
Wednesday, May 27, 2009
Sure, I got my information from a television commercial, but if you can’t believe television, what can you believe?
Wednesday, May 27, 2009
IVDMIA: Any Day Now?
One thing I can say for sure: IVDMIA's passage would significantly change risk calculations for LDTs that qualify as mutivariate.
Monday, November 17, 2008
One thing I can say for sure: IVDMIA's passage would significantly change risk calculations for LDTs that qualify as mutivariate.
Monday, November 17, 2008