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FDA Botanicals
Session Chair(s)
Douglas S. Kalman, PhD
Vice President, Scientific Affairs
Nutrasource, Canada
The FDA's relatively new and lesser known classification for Botanical Drug means the US joins many countries that offer practitioners and pateints high quality botanical medicines. Herbal medicines with a history of safety and efficacy, especially those that meet an unmet medical need, now have a track to regulatory approval.
Learning Objective : Describe the steps to create a scientific and business plan for the US FDA Botanical drug route; Identify the difference between FDA regulations for drugs, botanicals, homeopathic drugs and supplements; Discuss clinical considerations to evaluate the potential of a medicinal herb.
Speaker(s)
Executing US-FDA Compliant Botanical Drug and Dietary Supplement Studies: Regulatory Made Simple
Douglas S. Kalman, PhD
Nutrasource, Canada
Vice President, Scientific Affairs
Panelist
Daniel Fabricant, PhD
National Products Association, United States
Chief Executive Officer and President
Industry Update
Sue McKinney
Crinum Health Ltd, Singapore
Director
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