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Thursday, June 27 • 9:00am - 10:15am
#408: FDA Botanicals

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-722-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Douglas S. Kalman, PhD


Executing US-FDA Compliant Botanical Drug and Dietary Supplement Studies: Regulatory Made Simple
Douglas S. Kalman, PhD

Daniel Fabricant, PhD

Industry Update
Sue McKinney

avatar for Douglas Kalman

Douglas Kalman

Vice President, Scientific Affairs, Nutrasource
Douglas S. Kalman PhD, RD, FACN – Dr. Kalman has been involved in over 250 clinical trials and projects within the pharmaceutical, medical and exercise - nutrition related fields. He has published over 75 abstracts and more than 40 peer-reviewed manuscripts. He is a Co-founder of... Read More →
avatar for Sue McKinney

Sue McKinney

Director, Crinum Health Ltd
Sue is a California native, an attorney who has lived in Vietnam 25 years. She’s runs Crinum Health Ltd a biotech affiliated with cGMP facilities and organic plantations producing 100% vertically integrated proprietary botanicals – from farm-to-finished product. Vietnam is a bio... Read More →

Daniel Fabricant

Chief Executive Officer and President, National Products Association
Daniel Fabricant, Ph.D. is CEO and President of the Natural Products Association (NPA), the nation’s largest and oldest trade organization representing the natural products industry, including dietary supplements, foods, personal care products and more. Most recently, Dr. Fabricant... Read More →

Thursday June 27, 2019 9:00am - 10:15am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  06: PreClin Dev-EarlyPhaseCR, Session