FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER Releases Updated Policies Manual on Botanical Drugs

Nov. 14, 2016

The FDA’s Center for Drug Evaluation and Research has a revised its policies and procedures for the review of botanical drug products.

The MAPP was last updated in 2014, and this marks its fourth revision since its original publication more than a decade ago. The latest release is intended to help manage the unique issues associated with the review of botanical drug products and covers the responsibilities of each reviewer.

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