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In mid-August, FDA announced the availability of a draft guidance for industry, āBotanical Drug Developmentā ā a revision of a 2004 guidance. The general approach to botanical drug development has remained unchanged since the 2004 ļ¬nal guidance. However, based on improved understanding of botanical drugs and experience acquired in the reviews of NDAs and INDs for these drugs, speciļ¬c recommendations have been modiļ¬ed and new sections have been added to better address late-phase de-velopment and NDA submission for botanical drugs. It provides recommendations regarding development plans for botanical drugs to be submitted in new drug applications (NDAs) and speciļ¬c recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, it provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide rec-ommendations speciļ¬c to botanical drugs to be marketed under biologics license applications (BLAs), many scientiļ¬c principles described in this guidance may also apply to these products. The comment period extends to October 16.
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