180-Day Exclusivity: Questions and Answers; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``180-Day Exclusivity: Questions and Answers.'' This draft guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly is known as ``180-day exclusivity'' for generic drug products. As a general matter, FDA has implemented these statutory provisions within the context of application-specific decisions. Some FDA decisions have been made publicly available (e.g., in FDA citizen petition responses and documents released in litigation). FDA believes that a guidance for industry that provides answers to commonly asked questions about 180-day exclusivity would enhance transparency and facilitate the development, approval, and timely marketing of generic drug products. FDA intends to update this guidance to include additional questions and answers as appropriate.