Botanical Drug Draft Guidance

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In mid-August, FDA announced the availability of a draft guidance for industry, “Botanical Drug Development” – a revision of a 2004 guidance. The general approach to botanical drug development has remained unchanged since the 2004 final guidance. However, based on improved understanding of botanical drugs and experience acquired in the reviews of NDAs and INDs for these drugs, specific recommendations have been modified 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 specific 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 specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. The comment period extends to October 16.
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