D1S14-1-Larson-1.2-FINAL.pdf

1、Prioritizing Original and Supplemental ANDAsBayli Larson,PharmD,BCPSPharmacist,Patent and Exclusivity TeamDivision of Legal and Regulatory Support,Office of Generic Drug Policy,Office of Generic DrugsCDER|US FDASBIA Generic Drug Forum April 22,2026www.fda.govwww.fda.gov2Learning ObjectivesReview cri

2、teria that OGD uses to assess a valid prioritization request Recognize the most commonly used Prioritization Factors from Manual of Policies and Procedures(MAPP)5240.3 Rev.6Discuss key considerations when selecting a prioritization factor Provide an overview of the new Onshoring Prioritization Pilot

3、 www.fda.govwww.fda.gov31.The cover letter to the submission clearly states“Priority Review Requested”and references the ANDA number2.The basis for the request is consistent with MAPP 5240.3,Prioritization of the Review of Original ANDAs,Amendments,and Supplements3.The applicant clearly and briefly

4、states the basis for the request,including the prioritization factor(s)4.The applicant includes sufficient supporting documentation for the requestOr,in the absence of an explicit request,FDA determines the submission relates to a drug shortage,public health emergency,or meets the requirements of se

5、ction 505(j)(11)(A)of the FD&C ActThe Following Criteria Must be Met to be Consideredwww.fda.govwww.fda.gov4Common Prioritization Factors Submissions for which there are not more than three approved drug products Applications containing a paragraph IV certificationwww.fda.govwww.fda.gov5Prioritizati

6、on Factors Submissions for which there are not more than three approved drug products:No blocking patents or exclusivities listed for the reference listed drug(RLD)at the time FDA makes the prioritization determinationBlocking Patent:any patent that an ANDA applicant is required to address with a pa