The Trouble With Transparency
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
Sunlight may be the best disinfectant, but too much of it can cause melanoma.
Thursday, June 24, 2010
LDT: Legal Distinction Terminated
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 2010
LDTs Losing Enforcement Discretion?
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 2010
FDA no longer feels the need to bargain with industry about LDTs.
Wednesday, June 16, 2010
IVDMIA: to NPRM or Not to NPRM?
I can't rule out the possibility that the NPRM story is true, but it's certainly not an established fact.
Friday, March 05, 2010
I can't rule out the possibility that the NPRM story is true, but it's certainly not an established fact.
Friday, March 05, 2010
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
Clove Madness
You're not supposed to admire the work of lobbyists, but this is pretty impressive.
Monday, November 30, 2009
You're not supposed to admire the work of lobbyists, but this is pretty impressive.
Monday, November 30, 2009
The Incredible Shrinking LDT
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
I think it's safe to say that there is a shift in thinking at OIVD since Steve Gutman's departure.
Tuesday, September 22, 2009
"Square One" for IVDMIA?
FDA is probably executing a strategic retreat, not signaling their surrender.
Friday, August 14, 2009
FDA is probably executing a strategic retreat, not signaling their surrender.
Friday, August 14, 2009
A New, Tougher FDA?
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
The days of "black box" LDTs are likely drawing to a close.
Wednesday, July 29, 2009
Designed for (Future) Success
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 2009
The consequences of a poorly developed IVD product go well beyond a few negative postings in a blog.
Wednesday, June 10, 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
The Right Balance
What are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs?
Friday, May 08, 2009
What are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs?
Friday, May 08, 2009
Rumors
At this point, it's safe to say that IVDMIA will not be enacted under the Bush Administration.
Sunday, January 18, 2009
At this point, it's safe to say that IVDMIA will not be enacted under the Bush Administration.
Sunday, January 18, 2009
Genentech Citizen's Petition
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008
There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements.
Saturday, December 13, 2008
"Serious Misconduct" Alleged at CDRH
The more power an FDA approval holds, the more pressure may be brought to bear on those who make evaluations.
Tuesday, November 18, 2008
The more power an FDA approval holds, the more pressure may be brought to bear on those who make evaluations.
Tuesday, November 18, 2008
Creating Value in Difficult Times
How do you build value while you're cutting budgets?
Wednesday, November 12, 2008
How do you build value while you're cutting budgets?
Wednesday, November 12, 2008
IVD MIA -- But the guidance is still draft...
At the moment FDA is giving assay developers a choice as to whether or not CLIA labs want to bring their multivariate assays to FDA for review.
Saturday, September 20, 2008
At the moment FDA is giving assay developers a choice as to whether or not CLIA labs want to bring their multivariate assays to FDA for review.
Saturday, September 20, 2008