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Freddie Ann Hoffman

Freddie Ann Hoffman

Heterogeneity LLC, USA


Freddie Ann Hoffman, MD founded HeteroGeneity in 2003; a Washington, DC-based consultancy focused on complex natural products, and is also its Managing Member. She has over 35 years of product development experience. She has a BS in chemistry from UCLA and received her MD and General Pediatric Residency training from the University of California at Davis. She completed a fellowship in Pediatric Hematology-Oncology at the National Cancer Institute (NCI), staying on to direct the Nutrition and Supportive Care Section of the Division of Cancer Treatment, and later, as Director of Extramural Clinical Trials of the Biological Response
Modifiers Program. Leaving NCI in 1986, she served at FDA for nearly 14 years, as Chief of the Cytokines, Growth Factors and Oncologic Products Branch of the Center for Biologics Evaluation and Research, and later as Deputy Director of the Medicine Staff in the Office of the Commissioner. During her tenure, she formed and chaired an internal FDA Botanical Working Group which developed the botanical drug guidance, which the agency finalized in 2004. She also served in the Office of Dietary Supplements at the Center for Food Safety and Applied Nutrition, before moving to the private sector in 1999, joining Warner-Lambert Pfizer Consumer Healthcare, where she was Senior Medical Director for New Product Development. She continues to serve on numerous working groups, task forces, and boards of both government agencies and private companies. She has chaired and participated in numerous scientific, regulatory and policy forums addressing the development of polymolecular drugs and development of complex product. In 2014, she was an invited speaker at the 18th Presidential Commission on Bioethics (BRAIN initiative). She is a member of the American Society of Pharmacognosy and a past chair of the Drug Information Association’s Natural Health Products Track.


Abstract : Regulatory considerations of botanicals as new drugs for the US market