title: FDA critical path initiatives: opportunities for generic drug development.
abstract: FDA's critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document "Critical Path Opportunities for Generic Drugs" that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs.
authors.affiliation: Office of Generic Drugs, Food and Drug Administration, 7519 Standish Place, Rockville, Maryland 20850, USA. robert.lionberger@fda.hhs.gov
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lionberger
mesh_terms: D000818:Animals; D015195:Drug Design; D016568:Drugs, Generic / Q000138:chemical synthesis* / Q000592:standards*; D015507:Drugs, Investigational / Q000138:chemical synthesis* / Q000592:standards; D006801:Humans; D007885:Legislation, Pharmacy / Q000639:trends; D013678:Technology, Pharmaceutical / Q000379:methods / Q000639:trends; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends
chemical_list: D016568:Drugs, Generic; D015507:Drugs, Investigational