FDA webinar: Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions

FDA's Center for Drug Evaluation and Research has posted a pre-recorded webinar: "Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions." This webinar, and the guidance it accompanies, are intended to help applicants submitting an abbreviated new drug application (ANDA) seeking approval of a generic drug to identify:

• A reference listed drug (RLD), i.e., a previously approved drug product for which an applicant seeks approval of a generic drug;
• a reference standard, i.e., the previously approved drug selected by FDA that an applicant must use in conducting any in vivo bioequivalence testing required to support approval of its ANDA; and
• the basis of submission for the ANDA.

Additional Resources:

• Webinar
• Download Presentation Slides (PDF - 281KB) 
• Draft Guidance for Industry (PDF - 155KB) 
• Public Docket

For questions concerning the webinar, please contact CDER SBIA at: (866)-405-5367 | (301)-796-6707