FDA publishes final guidance for industry, Determining Whether to Submit an ANDA or 505(b)(2) Application

Today, the FDA published the final 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 section 505(j) and section 505(b)(2), identifies considerations to help applicants determine whether an application would be more appropriately submitted under either pathway, 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 Final Guidance:

• Helps applicants determine whether an application would be more appropriately submitted under either section 505(j) or section 505(b)(2)
• Provides applicants with direction on requesting assistance in making this determination
• Provides regulatory and scientific considerations for ANDA and 505(b)(2) applications

As part of the Commissioner’s Drug Competition Action Plan, the FDA is publishing this guidance to assist in clarifying the ANDA submission process, provide assistance to potential applicants, and ultimately expand access for patients to lower cost, high quality medicines.

For more information on determining whether to submit an ANDA or a 505(b)(2) application, FDA has published a webinar providing an overview of this guidance, which is available at: CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application. 

For further information, please visit: Final Guidance for Industry “Determining Whether to Submit an ANDA or 505(b)(2) Application”.