Botanical Drugs: A Regulatory Approach on how FDA Reviews a Botanical Application
Moderator: Nandakumara Sarma, Ph.D., United States Pharmacopeia
Presenters
Margaret M. Kober, R.Ph., M.P.A, Chief, Project Management Staff Division of Regulatory Operations for Urology, Obstetric, and Gynecology, DRORDPURM/ORO/OND/CDER/FDA – Understanding the FDA Application Process
Donna Christner, Ph.D, Branch Chief, DNDAPI, ONDP/OPQ/CDER/FDA – Processes for Quality Review of Botanicals: INDs, NDAs and DMFs
Charles Wu, Ph.D, Pharmacognosist, Botanical Team/ONDP IO/ONDP/OPQ/CDER/FDA – FDA’s Science-Based Approach to Botanical Drug Development
Rajiv Agarwal, Ph.D, Ph.D, Expert Regulatory Review Scientist (CMC of Botanicals), NDPB1, DNDP1/ONDP/OPQ/CDER/FDA – Botanicals as Drugs: CMC and Regulatory Challenges – Botanicals as Drugs: CMC and Regulatory Challenges
Sang Ki Park, PhD, DABT; Toxicologist; DPT-ID/OND/CDER/FDA – Nonclinical Safety Assessment for Botanical Drug Development
Mark Hirsch, MD, Medical Team Leader, DUOG/ORPURM/OND/CDER/FDA – Clinical Considerations
