FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

FDA Clarifies Botanical Drug Considerations for Combination Drugs

Jan. 5, 2017

The FDA updated its guidance for botanical drug development to include recommendations for navigating combination drug regulations, with possible criteria for receiving a waiver.

While current fixed-dose drug combination regulations require demonstrating the contribution of each active ingredient to overall safety and efficacy, the FDA said it recognizes that meeting that requirement with each raw botanical ingredient may not be feasible.

Whether that regulation applies to a specific botanical drug product depends on the type of mixture: for example, a product derived from a single plant source would not be considered a combination, because the entire botanical mixture is considered to be the active ingredient.

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