FDA + NGS = BFFs
We may be talking about a whole new regulatory paradigm when it comes to next-gen sequencing
Friday, June 24, 2011
We may be talking about a whole new regulatory paradigm when it comes to next-gen sequencing
Friday, June 24, 2011
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
RU O Kidding? OMG!
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
Draft RUO / IUO FDA Guidance Document Officially Released
Wednesday, June 01, 2011
Rant Utility Obvious
Because "only" is such a difficult word to interpret
Thursday, December 23, 2010
Because "only" is such a difficult word to interpret
Thursday, December 23, 2010
Can I Get an EUA Too?
The short answer is no, you probably can't get an EUA. Not unless you're the CDC or the stars have all come together for you just right.
Thursday, April 30, 2009
The short answer is no, you probably can't get an EUA. Not unless you're the CDC or the stars have all come together for you just right.
Thursday, April 30, 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