Modern herbal medicines come in formats of pills or capsules. Their safety and efficacy have been demonstrated by daily use on large populations. Identifying already known safe and effective herbal medicines with the potential to be developed as US prescription botanical drugs is an efficient drug development pathway. ABDA promotes FDA botanical drug guidance and collaborates with entities around the globe to develop research and development of herbal medicines.
Because herbal medicine companies are often small and lack sufficient funding to take their products through the entire FDA IND process, ABDA advocates a collaborative approach in which herbal medicine companies conduct preclinical studies and file for FDA botanical drug pre-IND and phase 1 IND. Then, herbal medicine manufacturers out-license the products for late-stage development. Herbal medicine manufacturers can repeat the process for several products till they have the financial strength to advance the drug product clinical development all the way to the market by themselves.