The availability of generic drug products can mitigate the risk of drug shortages, help make prescription drugs more affordable, and enhance patient access to medicines. However, there may be substantial uncertainty about how to approach the development of complex generic drug products (CGDPs). The complexity of CGDPs may be associated with the active pharmaceutical ingredient (API), the formulation, the dosage form, the route of delivery, and/or the nature of the drug-device combination product. To encourage CGDP development, the Food and Drug Administration (FDA) is actively engaging with prospective developers of CGDPs to discuss specific issues of scientific or regulatory complexity, and to clarify the FDA’s bioequivalence (BE) standards and recommendations.
This practical, active-participation workshop will help participants learn how to approach a demonstration of API sameness and BE for each type of CGDP and how to engage with the FDA about different types of questions during the development of a CGDP. Workshop participants will learn how to efficiently de-risk CGDP development, increase certainty about regulatory decision making, and enhance patient access to high-quality CGDPs. The unique focus of this workshop is that participants will gain hands-on experience, learning through mentoring and interactive practice how exactly to implement the concepts, information, and procedures covered in those other workshops.