Wednesday, March 15, 2017

Chemistry, Manufacturing and Controls for New Drug Applications


My primary function as the Chemistry Reviewer and Team Leader in the Division of Anti-Infective Drug Products ( New Drugs Chemistry), when I was still working for FDA was to insure that all chemistry, manufacturing and controls(CMC) requirements are followed by the Pharmaceutical companies before their new drug application are approved for marketing.

I had worked for FDA for 12 years. It was of my most satisfying and productive job in my more than 22 years of professional career here in the United States. Working for FDA was the best move I have ever made in my career. My 12 years in the FDA was filled with awards, accomplishments and personal growth. Our life in the suburb of Washington, DC was filled with civic involvements, social and cultural activities, humanitarian projects and pleasant memories. The highlight of our stay in the Washington, D.C area was a private tour of the WHITE HOUSE.

A couple of years ago, I posted this article in my blogs. However, recently I hired a new gardener. He was very friendly and asked me what I was doing before my retirement. I told him to visit my site. I am not sure if my gardener is computer savvy, but he is young and appeared to be curious and intelligent. I hope he reads this:

http://chateaudumer.blogspot.com/2013/12/chemistry-manufacturing-and-controlscmc.html

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