FDA Enforcement Trends

Week of October 21st 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 10 warning letters this week: 8 of them citing unapproved or misbranded new drugs with problematic websites as the source of FDA’s information. Along with this, 1 warning letter was published that was issued to a compounding pharmacy.

Week of September 30th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.