Getting DTC Genomics Right
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 2010
Personal genomics must move beyond the phase of repackaging preliminary research as actionable information.
Friday, May 21, 2010
Pathway's Looming World of Hurt
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
Thank your for your willingness to invite FDA enforcement in public.
Wednesday, May 12, 2010
Pathway's Direct-to-Recall Marketing
The perils of making a deal to sell an unapproved IVD direct to consumer.
Tuesday, May 11, 2010
The perils of making a deal to sell an unapproved IVD direct to consumer.
Tuesday, May 11, 2010
FDA Trims the Astroturf
FDA may actually expect you to behave the way you're supposed to.
Thursday, May 06, 2010
FDA may actually expect you to behave the way you're supposed to.
Thursday, May 06, 2010
Unicorns, Santa Claus and Instrument-Only Clearances
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
Let's be clear, though: the world has not turned topsy-turvy today.
Tuesday, May 04, 2010
Careful with Claims
It can be frustrating to 'just know' your product can do more, but making claims that are not truly validated is simply unwise.
Monday, May 11, 2009
It can be frustrating to 'just know' your product can do more, but making claims that are not truly validated is simply unwise.
Monday, May 11, 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