Donald Holsten, Pharm D., a regulatory consultant and educator with over 20 years of national and international experience as a senior regulatory affairs and quality assurance executive, has expertise in food, drug/biopharmaceutical, medical device and cosmetic products. He has an intimate knowledge of the FDA approval cycle and has helped prepare numerous biotechnology and pharmaceutical companies for FDA interactions and panel reviews. Don has held management positions at several companies, including Liposome Technology, Inc and Oclassen Pharmaceuticals, Inc. where he was Director of Regulatory Affairs/Quality Assurance and Director of Regulatory Affairs, respectively. Earlier in his career, he held a senior level position as Assistant Chief, Food and Drug Branch, Department of Health Services for the State of California.
Cosmetics, a less discussed sector of the life sciences industry, is covered by FDA and other country regulations. The worldwide arena has had some very interesting developments about which Dr. Holsten will provide an update.
