D1S14-2-Kim-1.2-FINAL.pdf

1、Prioritization Requests CDR Andrew Kim,PharmD,RACSupervisory Project Manager,Division of Project Management Office of Regulatory Operations,Office of Generic Drugswww.fda.govwww.fda.gov2Learning Objectives What is Priority Review and the benefits Describe process for prioritizing original ANDAs,amen

2、dments and supplements Roles and Responsibilities List Common Mistakes to Avoid when submitting a prioritization requestwww.fda.govwww.fda.gov3Poll QuestionWhich of the following is not true?A.Original ANDA or amendment must meet one of the prioritization factors in MAPP 5240.3 to qualify for priori

3、ty reviewB.An ANDA supplement that addresses a public health emergency qualifies for priority reviewC.FDA will evaluate whether a priority review will be granted without an explicit request from applicant at time of submissionD.Submissions that are eligible for priority review may receive a shorter

4、goal date or expedited reviewwww.fda.govwww.fda.gov4Key Points What is Priority Review Benefits How to Request Priority Reviewwww.fda.govwww.fda.gov5BenefitsShorter Goal Dates(GDUFA III):Original ANDAs:8-month goal date Major Amendments:6-or 8-month goal date Prior Approval Supplements:4-or 8-month

5、goal date Expedited Review(No change to Goal Date):FDA strives to act as soon as possible May complete review prior to goal datewww.fda.govwww.fda.gov6Priority Review ProcessSubmission ReceivedEvaluationCoordinationDeterminationReview Proceedswww.fda.govwww.fda.gov7Roles and Responsibilities OGD RPM

6、s OPQ RBPMs&OGD Labeling PM OGD Division of Filing Review Office of Generic Drug Policywww.fda.govwww.fda.gov8Common Mistakes Timing Request priority review with each cycle Facilities Cover letterwww.fda.govwww.fda.gov9Summary Shorter Goal