Approval of botanical NDAs is possible
A practical approach for quality control of botanical products can be developed
Raw material controls required
Clinically relevant specifications for drug substance/product can be established if multiple batches are used in the pivotal clinical trials
Other data, e.g., from bioassay and/or multiple-batch, and from dose response clinical trials, may be needed in conjunction with conventional CMC data, to help ensure therapeutic consistency
Clinical trials of botanical drugs are no more difficult than non-botanical drugs