IVD Roundtable Meeting Recap
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
No knights, but plenty of great discussion nonetheless.
Monday, June 13, 2011
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
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
Hologic HPV Approvals
This approval clearly demonstrates the FDA’s willingness to work with diagnostic companies on state-of-the-art molecular diagnostic testing.
Friday, April 10, 2009
This approval clearly demonstrates the FDA’s willingness to work with diagnostic companies on state-of-the-art molecular diagnostic testing.
Friday, April 10, 2009
IVD's and LDT's - What's the difference?
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009
Molecular diagnostic tests have two compliant paths to the US market.
Wednesday, April 08, 2009