PDF-Center for Drug Evaluation and Research (CDER) Clinical/Antimicrobial

Author : liane-varnes | Published Date : 2015-11-23

Additional copies are available from Office of Communications Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001

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Center for Drug Evaluation and Research (CDER) Clinical/Antimicrobial: Transcript

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. 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, 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 B 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 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- Melanie Hartsough, Ph.D.. Biologics Consulting Group, . Inc. 1. CDER: approximately 3,600 FTEs in 2013. 18 review divisions-divided based on . indication. CDER: average of 26 NMEs approved per year. Due to volume of work try to standardize requirements. JMH House staff Orientation 2012. Lilian Abbo, MD. Assistant Professor Clinical Infectious Diseases. Laura Smith, . PharmD. . Infectious Diseases Clinical Pharmacist. What is Stewardship?. Selection. Regulations. An Environment of Change. Brian Lubbers, DVM, PhD, . DACVCP. Director of Clinical Microbiology. Changing Regulations. Cephalosporin . Extralabel. Use Restriction. FDA Guidance 209. FDA Guidance 213. 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 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 RESISTANCE Interagency Task Force on Antimicrobial Resistance Co - Chairs: Centers for Disease Control and Prevention Food and Drug Administration National Institutes of Health Participating Agencie s 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

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