PDF-MANUAL OF POLICIES AND PROCEDURESCENTER FOR DRUG EVALUATION AND RESEAR

POLICY AND PROCEDURES Office of ManagementRestoration of Forfeited Annual Leave Table of ContentsBACKGROUNDPOLICY BACKGROUNDThis MAPP provides information on the restoration of forfeited annual leave. 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 7 Originator Office of New Drug Quality Assessment Effective Date 2212007 1132007 2272014 Page CENTER FOR DRUG EVALUATION AND RESEARCH Acceptability of Standards from Alternative Compendia BPEPJP CONTENTS PURPOSE BACKGROUND DEFINITION POLICY RESPONS 2 Rev 1 Office of the Center Director Resolution of Differing Professional Opinions Review by Ad Hoc Panel and CDER Director CONTENTS BACKGROUND POLICY RESPONSIBILITIES PROCEDURES REFERENCES DEFINITIONS EFFECTIVE DATE PURPOSE This MAPP provides the MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 6025.4 MAPP focuses primarily on interpretations ofand direction to CDER staff.e application can lead to an RTF action. POLICY AND PROCEDURES OFFICE OF PHARMACEUTICAL SCIENCE Table of ContentsPURPOSBACKGROUND MANUAL OF POLICIES AND PROCEDURESCENTER FOR DRUG EVALUATION AND RESEARCHMAPP 5016.4 Originating Office: Office Originating Office: Office of the Center Director Effective Date: 6/8/09; 12/20/11 Page 1 of 7 OFFICE OF THE CENTER DIRECTOR Tracking of Significant Safety issues in Ma BACKGROUND Originating Office: Office of New Drugs Effective Date: 3/9/15 Page 1 of 11 POLICY AND PROCEDURES OFFICE OF NEW DRUGS Table of Contents PURPOSE ........................................... Originating Office: Office of the Center Director Effective Date: 11/13/95; 09/28/06: 9/3/2014 Page 1 of 24 POLICY AND PROCEDURES OFFICE OF THE CENTER DIRECTOR BACKGROUND ........................ Originating Office: Office of ManagementEffective Da06/1/2015 POLICY AND PROCEDURES OFFICE OF MANAGEMENTMonitoring and obligatingUndelivered Orders (UDOs) Table of Contents PURPOSEThisMAPPclarifiesth Originator: Office of New Drug Quality AssessmentEffective Date: 2/21/200711/3/20072/27/2014Page CENTER FOR DRUG EVALUATION AND RESEARCHAcceptability of Standards from AlternativeCompendia(BP/EP/JP ; 09/16/10 Page 1 of 8 Office of the Center Director Review by Ad Hoc Panel and CDER Director BACKGROUND POLICY REFERENCES EFFECTIVE DATE PURPOSE aluation and Research (CDER) staff a procedure t POLICY AND PROCEDURES Office of ManagementRestoration of Forfeited Annual Leave Table of ContentsBACKGROUNDPOLICY BACKGROUNDThis MAPP provides information on the restoration of forfeited annual leave Originating Office: Office of New Drugs Effective Date: 5/1/98; 11/7/07; 2/26/15 Page 1 of 5 POLICY AND PROCEDURES Table of Contents BACKGROUND submitted by the applicant in response to