D1S16-Quach-v1.2-FINAL.pdf

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1、How Orange Book Listings AreAdded,Updated,and MaintainedA practical look at Orange Book database workflowsTruong Quach,PharmDLead PharmacistOffice of Generic Drugs Office of Generic Drug Policy Division of Orange Book Publication and Regulatory Assessment(DOBPRA)CDER Generic Drug Forum April 22,2026

2、2By the end of this session,you should be able to:Understand workflows behind Orange Book entriesDescribe common update triggers Understand Orange Book publication cadence Know where and how to request updatesOBJECTIVESwww.fda.gov3Background of the Publicationwww.fda.gov1980 First edition 1984 FD&C

3、Act amended to require FDA to publish and regularly update info in Orange Book1985 6th Edition of the Orange Book Annual Publication discontinued drug products designated by special symbol1987 7th Edition of OB Annual added the Discontinued section2026 46th Orange Book Edition published in January4E

4、lectronic Orange Book Databasewww.fda.gov5Where Orange Book Data Comes Fromwww.fda.govNew drug product line listing Original approval,e.g.,505(b)NDA,505(j)ANDA Supplements Therapeutic equivalence(TE)evaluations Reference listed drug(RLD)and reference standard(RS)designationsOther listed product info

5、rmation Patent submissions(Form FDA 3542)and exclusivity listings Safety and effectiveness determinations for discontinued drug productsRevisions to listed information Marketing status notifications(506I)Ownership changes and name changes(refer to 21 CFR 314.72)6Patents&Exclusivity:What Gets Listed(

6、and How)www.fda.govNDA holder submits patent information Submitted to FDA on Form FDA 3542 DOBPRA reviews for technical completeness(ministerial role)Orange Book records patent fields Patent number,expiry date,Drug Substance(DS),Drug Product(DP),patent use code(for method-of-use(MOU)patents)Patent s