橙皮书药品上市-Quach.pdf

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1、Orange Book Drug Marketing StatusTruong Quach,PharmDLead PharmacistOffice of Generic Drugs Office of Generic Drug Policy Division of Orange Book Publication and Regulatory Assessment(DOBPRA)CDER|U.S.FDAGeneric Drug Forum April 10th,2024fda.gov/cdersbiafda.gov/cdersbia2 Present a brief history of the

2、 Orange Book Describe the basics of marketing status changes Describe 506I marketing status report requirements Discuss three case studies on 506I marketingObjectivesfda.gov/cdersbiafda.gov/cdersbia31980 1stOrange Book Edition publication1984 Passage of the Drug Price Competition and Patent Term Res

3、toration Act(Hatch-Waxman Amendments)Approved prescription drug products with therapeutic equivalence evaluation1985 6thEdition of the Orange Book annual publicationFDA began identifying discontinued drug products in the Prescription Drug Product List section in the Orange Book1987 7thEdition of the

4、 Orange Book annual publicationA distinct Discontinued Drug Product List(Discontinued Section)was created in the Orange Book publicationBackground of the Publicationfda.gov/cdersbiafda.gov/cdersbia4 1.11 Discontinued Section 1.12 Changes to the Orange BookOrange Book Prefacefda.gov/cdersbiafda.gov/c

5、dersbia5When and how often is the Orange Book updated?Information is updated by website and as downloadable PDFs.Updates are made daily,semi-monthly,monthly and annual basisWhat information is included in the updates?Daily website updates:patent information and new generic drug approvals Semi-monthl

6、y website:all changes which occurred in the current month.Monthly data files update consist of all changes to Orange Book which occurred in the prior month.Print Annual Edition of Orange Book consist of full copy of all the changes in the Orange Book which occurred in the prior year.Publication Freq