Health Law Advisor

Overview

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter.  In this exercise, I do not try to prove causation.  I am simply exploring correlation.  But with that caveat in mind, I think it’s still informative to see what types of inspectional citations, in a high percentage of cases, will precede a warning letter.  And, as I’ve said before, joining two different data sets – in this case inspectional data with warning letter data – might just reveal new insights.

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed, and, concurrently, published revised draft guidance titled Drug Products Labeled as Homeopathic (the “Revised Homeopathic Draft Guidance”).

Homeopathy—an alternative medical approach that began in the late 18^th century—is based on the belief that (1) a substance that causes symptoms in a healthy ...

On April 2, 2019, FDA issued a press release featuring a statement from FDA Commissioner Scott Gottlieb announcing the Agency’s latest enforcement actions taken against companies engaging in unlawful marketing of cannabidiol (CBD) products.  Coming just days before Gottlieb’s anticipated departure from the Agency, this news otherwise is unsurprising given recent events on the federal and state level.  In a December 2018 press release issued on the heels of the Farm Bill’s passage, FDA forecast its intention to step up enforcement against CBD products, and earlier this year ...