Regulatory review and approval - an underappreciated barrier to commercialization

Abstract: New chemical innovators may be aware of the requirement for regulatory review and approval for new active pharmaceutical ingredients. Innovators may be surprised that other products have other review burdens and those burdens depend on the country in which the product will be launched, the tonnage manufactured or imported, and the target uses. In the United States, there are very different burdens for food, drugs, medical devices, cosmetics, and components thereof under the Federal Food, Drug, and Cosmetics Act (FFDCA), pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and “everything else” under the Toxic Substances Control Act (TSCA). In this presentation, attendees will learn about the timeframes and cost for testing, submission, review, and approval by regulators in major markets and the need to be clear with investors about the costs and timing of pre-market approval.