PDF-____________________________ Center for Drug Evaluation

Additional copies are available from Office of CommunicationsDivision of Drug Information WO51 Room 2201Center for Drug Evaluation and ResearchFood and Drug Administration 10903 New Hampshire Ave. 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 Software Testing Qualifications Board Name:____________________________ Company address:____________________________ ____________________________ ____________________________ Phone :__________________ Center for Drug Evaluation and ResearchU.S. Food and Drug Administration U.S. Health and Human Services Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDA’s BALANCE Rater Name: ____________________________ SCALE Date: ____________________________ Balance Item Score (0-4) 1. Sitting unsupported _______ 2. Change of positi 3. Change of position” st 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 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 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 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 10001 New Hampshire Ave., Hillandale B