Week of January 6th 2019 | FDA Sent These Warning Letters to Pharma/Device Companies
No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere.
FDA Cites Part 11 in Clinical Trial
We all “know” FDA doesn’t cite Part 11 in 483s, right? Well, maybe.
Week of December 16th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
This week, one warning letter was issued by CDER to a finished pharmaceutical manufacturer, and another was issued to a Genetech site that manufactures human cells/tissue-based products.
Week of December 9th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
FDA posted four warning letters this week including one to an API manufacturer, one to a compounding pharmacy and one to a drug product manufacturer.
Week of December 2nd 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
We compiled last week's warning letters for you. Take a look.
FINAL Part 3: Who’s Who? Seeing CROs Clearly.
Clinical service provider or CRO? Observations of FDA enforcement.
Week of November 25th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies
Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
Part 2: Who’s Who? Seeing CROs Clearly.
EDC or CRO? Perceptions of data control.
Part 1: Who’s Who? Seeing CROs Clearly.
When is a CRO not a CRO? A look at 21 CFR Part 312.