Formulation and Delivery
Sam Raney, PhD
Associate Director for Science
US Food and Drug Adminstration
Silver Spring, Maryland
Jaymin Shah, PhD
Research Fellow and Head of Topical and Advanced Drug Delivery
Pfizer Worldwide Research and Development
Groton, Connecticut
Complex generic products earned their name because many have complex active ingredients, dosage forms, routes of administration, or drug-device combinations. Examples of complex products include inhalers, topical products, and extended release injectables. Generics of complex brand name drugs or reference listed drugs can be more difficult to develop. As drugs have increased in complexity in recent years, the scientific and regulatory roadmaps for drug development and approval may not be as well-established for more complex generics. As such, a complex drug product is less likely to have an available generic. To enhance patient access to all types of generic medicines, FDA has a robust research program that addresses numerous specific scientific challenges that have historically delayed access to these medicines, including complex generics. The scientific advances and regulatory outcomes from this research program will be highlighted during this presentation.