PDF-CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: STATISTI

US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Translational Sciences Office of BiostatisticsTATISTICAL EVIEW AND VALUATIO. DFXED LYLVLRQ57347RI57347DVWURHQWHURORJ DQG57347QERUQ57347UURU 3URGXFWV LFKDUG5734757355HV5735657347VKLKDUD ULDQ573476W URQJLQ LYLVLRQ57347RI 3XOPRQDU OOHUJ 5735957347DQG573475KHXPDWRORJ 3URGXFWV 6DQG57347DUQHV LYLVLRQ57347RI573470HWDEROLVP57347DQ 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 GUIDANCE ON THE PACKAGING OF TEST BATCHES CONTENTS PURPOSE BACKGROUND Originator: Director, Office of Generic Drugs 11/1/95, recertified: 09/05/2012 Page 1 • To provide inf 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 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 DIVSION OF CARIO-RENAL DRUG PRODUCTSDivisional MemoNDA: 22-425 (Multaq; dronedarone for atrial fibrillation andatrial flutter)Sponsor: sanofi-aventisReview date: 27 March 2009Reviewer:N. Stockbridge, naïve subjects infected with CCR5-tropic HIV-1. In the 2 trials of treatment-experienced supported an indication for treatment of treatment-experienced patients infected with CCR5-tropic HIV-1. Pl