All posts by Martin A. Lessem, J.D.

A regulatory attorney working as a Director of US Regulatory Affairs in the Pharma Industry with ten years experience in Regulatory Affairs in both Clinical and Post-Marketing areas. Martin has planned US Regulatory Strategies and managing the Regulatory Activities in the US for a multi-national company. Currently he is working on Labeling for Biological products with another multi-national company.

Deconstructing “200 Evidence Based Reasons NOT To Vaccinate”

So I was checking out my Facebook page when I stumbled across an article, entitled “200 Evidence Based Reasons NOT To Vaccinate” [PDF download] posted by a physician friend. He and I often post medically related articles for a laugh, and every so often, we stumble across something like this, and share it with those whom we know will laugh at the...

/ May 3, 2015

Marketing Pharmaceuticals in today’s Regulatory Environment

In the comments to my previous article I had said I would tackle the topic of how Pharmaceutical Products are marketed and how the FDA is involved in that process. Then I managed to get a new job with a different company, and have been busy getting up to speed. I still do the same thing, but with a different company and...

/ May 5, 2011

The FDA for the Average SBM Consumer

How the Food and Drug Administration came to be is a story that is filled with death, intrigue and dubious characters. It also, like most stories, has its share of heroes and vindications. The list of those who have died to bring us the agency we know today is long, but even today, the death-toll continues. Now this is not the horrible...

/ June 24, 2010