Hello All,
I wrote a blog post on FDA Warning Letters for 2017. For the post, I compiled all of the Warning Letters issued last year and filtered looking for trends based on who issued the Warning Letter (Center or District) and the topics most heavily cited. It doesn't get much attention on RAPS but CTP is becoming a hub of activity - jumping to 81 Warning Letters last year thanks to the Deeming Regulation. By comparison, CDER issued 83 Warning Letters. It's not an exact science, but the tables provide some insight into the bigger enforcement picture.
FDA Warning Letters 2017 - FDA Attorney
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| FDA Warning Letters 2017 - FDA Attorney |
| FDA Warnings 2017 is a post looking back at all 504 Warning Letters issued last year to look for trends and lessons to apply in 2018. |
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Best,
Marc
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Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
United States
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