PDF-CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5225.1

GUIDANCE ON THE PACKAGING OF TEST BATCHES CONTENTS PURPOSE BACKGROUND Originator Director Office of Generic Drugs 11195 recertified 09052012 Page 1 149 To provide inf. DFXED LYLVLRQ57347RI57347DVWURHQWHURORJ DQG57347QERUQ57347UURU 3URGXFWV LFKDUG5734757355HV5735657347VKLKDUD ULDQ573476W URQJLQ LYLVLRQ57347RI 3XOPRQDU OOHUJ 5735957347DQG573475KHXPDWRORJ 3URGXFWV 6DQG57347DUQHV LYLVLRQ57347RI573470HWDEROLVP57347DQ 1 REVIEW MANAGEMENT IND Process and Review Procedures Including Clinical Holds CONTENTS PURPOSE REFERENCES DEFINITIONS POLICY GENERAL REVIEW PRINCIPLES RESPONSIBILITIES AND PROCEDURES EFFECTIVE DATE PURPOSE This MAPP describes General review principl 6 POLICY AND PROCEDURES OFFICE OF NEW DRUGS Good Review Practice Management of Breakthrough TherapyDesignated Drugs and Biologics Table of Contents PURPOSE 1 BACKGROUND Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 dr ilable from: Dsion of Drug Information 101 New Hampshire Ave. 0993 1-847-8714 ov yInformation/Guidances/default.htmAdditional copies are avaOffice of Communications iviSilver Spring, MD 2Phone: 301- Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm Additional copies are available from: Office of Communication Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.,Bldg. 51, Room Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 dr Additional copies are available from Office of Communications Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave Hillandale Bldg NDA 206353 ATV/COBI FDC CDTL Review mentioned phase III trialand a phase IItrialTrialGS-US-216-0105 as reviewed in NDA The findings of this study was extrapolatedto HIV-1treatment-experienced patients Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale B