FDA publishes draft guidance for industry, Determining Whether to Submit an ANDA or 505(b)(2) Application
Today, the FDA published the draft guidance for industry “Determining Whether to Submit an ANDA or 505(b)(2) Application,” which serves as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, & Cosmetic Act is appropriate for the submission of a marketing application for a human drug product to the FDA. The guidance highlights criteria for applications under both pathways, identifies considerations to help applicants determine whether an application would be more appropriately submitted under either section 505(j) or section 505(b)(2), and provides direction to applicants on requesting assistance in making this determination. The guidance is one of a series of documents designed to enhance and clarify regulatory expectations for the abbreviated approval pathways, thereby advancing innovation, encouraging competition, and promoting access to safe, effective, and affordable medicines. The agency will announce more information about these additional documents in the coming months.
To comment on the draft guidance, please visit the public docket, FDA-2017-D-5974.
Additionally, the FDA has recorded a webinar providing an overview of this guidance. The presentation and accompanying slides are now available on FDA.gov.