Navigating US FDA Regulatory and Development Pathways for Botanical Drug Products

Navigating the US FDA regulatory pathways for botanical drug products is a daunting task. The June, 2004, FDA Guidance for Industry: Botanical Drug Products offers a basic roadmap, but experiences in natural product drug development suggest a deeper level of understanding is required to avoid costly delays. The information submitted in an IND will depend in part on the novelty of the drug, its history, known or suspected risks, the intended clinical population and development phase of the drug. Sponsors often are faced with wondering how much characterization and process control is enough for early stage clinical products. Balancing development costs and timelines against the need for characterization and process definition requires knowledge of Agency expectations as well as the capabilities of current advancements in science and technology. As you approach late stage clinical manufacturing, process understanding and positioning within the regulatory documentation becomes critical to the product's commercial viability and likelihood of approval. Likewise, the environmental and non-clinical safety assessments may add significant costs and delays to development if not well understood at the onset. Consultations with the Agency are encouraged, but well justified approaches must be developed prior to entering into discussions and negotiations with FDA in order to protect your overall development strategy without engaging unnecessarily in costly studies often adding 6 to 12 months to a program's timeline.