Happy multi-generation family holding Thanksgiving turkey together at dining table.

Hope at This Time of Giving Thanks

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,

Homeopathic Drugs Moving Closer to the Front Burner

The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products.  This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017.

FDA Blasts Shots Over the Bow to Four Homeopathic Firms for CGMP Violations

 

In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products.  The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over twenty-five years (twenty‑seven years now).