FDA's Center for Drug Evaluation and Research has posted a pre-recorded webinar: "Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions."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.
- 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- Draft Guidance for Industry (PDF - 155KB)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