Blog Posts with Tag: Warning Letters

RUO Enforcement Begins?
FDA throws down the gauntlet
Friday, September 30, 2011
Pathway's New World of Hurt
Finding the quickest pathway to a warning letter
Wednesday, September 28, 2011
LDT: Legal Distinction Terminated
OIVD will no longer observe a significant distinction between IVDs and LDTs.
Monday, June 21, 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
FDA Trims the Astroturf
FDA may actually expect you to behave the way you're supposed to.
Thursday, May 06, 2010
New Carrots, New Sticks
Top impressions from Dr. Hamburg's FDLI remarks
Friday, August 07, 2009

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