FDA Enforcement Trends

Week of September 9th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.

Week of August 26th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 13 new warning letters this week including 7 issued by the Center for Tobacco Products, 1 to a device firm, and 1 to a compounding pharmacy. Four warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol. Both the device firm and pharmacy letters are covered in this post.

2015 vs 2018 – MHRA Data Integrity Guidance

MHRA published a revision to their 2015 Data Integrity Guidance. The 2018 revision, in general, provides more detail and granularity than the 2015 version. Several items from the 2015 version are absent from the 2018 version. However, some items are more detailed in the 2018 version. We address all within this post and identify the nature of the addition, deletion, or revision.

FINAL Part 3: Invisible Ink in GLP and GCP Research

“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”

The New FDA GMP Inspection Model

While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.