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2834FDA Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy
2835FDA Draft Guidance for Industry, Clinical Laboratories, and FDA Staff In Vitro Diagnostic Multivariate Index Assays DRAFT GUIDANCE
2839Eudralex Volume 3 Medicinal Gases: Pharmaceutical documentation (CPMP/QWP/1719/00 Rev 1)
2840EU GMP Q9 Quality Risk Management
2841FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Reclassification of Automated Blood Cell Separator Device Operating by Filtration Principle from Class III to Class II
2842FDA Guidance for Industry and FDA Staff Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
2844Eudralex Volume 3 Adopted Guideline (Radiopharmaceuticals)
2845Eudralex Volume 3 Draft Guideline (Radiopharmaceuticals)
2846FDA FEDERAL REGISTER Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay
2847Eudralex Volume 3 Concept paper
2848Eudralex Volume 3 Human cell-based medicinal products
2849Eudralex Volume 3 Concept Paper for the revision of Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products
2850Eudralex Volume 3 Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells
2851Eudralex Volume 3 The replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products
2852Eudralex Volume 3 Concept Paper: Revision of the Note for guidance on Plasma-Derived Medicinal Products
2853Eudralex Volume 3 Draft : Revision of CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products
2855Eudralex Volume 3 Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture
2857FDA Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
2858FDA Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
2859FDA Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
2862FDA COMPLIANCE POLICY GUIDE Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)
2864FDA COMPLIANCE POLICY GUIDES - Foreword
2867FDA Guidance for Industry Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
2869FDA Guidance for Industry Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts DRAFT GUIDANCE
2870FDA PHS GUIDELINE ON INFECTIOUS DISEASE ISSUES IN XENOTRANSPLANTATION
2873FDA Guidance For Industry Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans
2874FDA Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
2875FDA COMPLIANCE PROGRAM GUIDANCE MANUAL Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002
2876FDA Compliance Program Chapter 41 - Therapeutic Products Inspection of Tissue Establishments 7341.002A
2877FDA Compliance Program Guidance Manual Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001
2878FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002
2879FDA COMPLIANCE PROGRAM GUIDANCE MANUAL Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) 7342.007 Addendum
2880FDA Compliance Program Chapter 42 - Blood and Blood Products Inspection of Licensed Viral Marker Test Kits 7342.008
2881FDA Compliance Program Guidance Manual Chapter – 45 Biological Drug Products Inspection of Biological Drug Products (CBER) 7345.848
2882FDA Guidance for Industry Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
2883FDA Guidance for Industry Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
2884FDA Guidance for Industry Characterization and Qualification of Cell Substrates and Other Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications DRAFT GUIDANCE
2886FDA Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
2888FDA FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
2889FDA FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order
2890FDA COMPLIANCE POLICY GUIDES - Introduction
2891FDA COMPLIANCE POLICY GUIDE Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (CPG 7150.13)
2892FDA Guidance for Industry FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
2893FDA COMPLIANCE POLICY GUIDE Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16) Page 5
2894FDA Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE
2896FDA Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
2897FDA Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product
2898FDA Guidance for Industry How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)
2901PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING (PI 037-1)
2902FDA FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
2903FDA FEDERAL REGISTER Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
2904EU GMP Q10 Pharmaceutical Quality System
2905FDA Guidance for Industry Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
2906FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
2907FDA Guidance for Industry Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests
2908FDA Guidance for Industry Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies DRAFT GUIDANCE
2909FDA Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
2910FDA Guidance for Industry Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements
2911FDA FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction
2912FDA FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule and Notice
2913FDA Guidance for Industry MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2914FDA FEDERAL REGISTER Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue- Based Product Establishments; Inspection and Enforcement; Final Rule
2915FDA Guidance for Industry Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2916FDA FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction
2917FDA COMPLIANCE POLICY GUIDE Sec. 140.500 Metric Declarations of Quantity of Contents on Product Labels (CPG 7150.17)
2918FDA COMPLIANCE POLICY GUIDE Sec. 300.100 Inspection of Manufacturers of Device Components (CPG 7124.15)
2919FDA FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule
2921FDA FEDERAL REGISTER Combination Products Containing Live Cellular Components; Public Hearing
2922FDA Guidance for Industry Validation of Procedures for Processing of Human Tissues Intended for Transplantation
2923FDA Human Cells or Tissues Intended for Transplant Into a Human Recipient That Have Ex-vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs Letter
2924FDA COMPLIANCE POLICY GUIDE Sec. 400.100 Drugs, Human - Failure to Register (CPG 7132.07)
2925FDA Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
2926FDA Guidance for Industry Screening and Testing of Donors of Human Tissue Intended for Transplantation
2927FDA COMPLIANCE POLICY GUIDE Sec. 400.200 Consistent Application of CGMP Determinations (CPG 7132.12)
2928FDA COMPLIANCE POLICY GUIDE Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)
2929FDA COMPLIANCE POLICY GUIDE Sec. 400.900 Class I Recalls of Prescription Drugs (CPG 7132.01)
2930FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs
2931FDA Guidance for Industry Pharmacogenomic Data Submissions
2933FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments
2934FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications
2935FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies
2936FDA Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions DRAFT GUIDANCE
2938FDA Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
2939FDA Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
2941FDA Guidance for Industry Providing Regulatory Submissions to CBER in Electronic Format — Investigational New Drug Applications (INDs)
2942FDA Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees
2943FDA Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information
2944FDA Guidance for Industry Acceptance of Foreign Clinical Studies
2945FDA Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
2946FDA Guidance for Industry Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
2947FDA Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
2949FDA Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
2951FDA Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products
2952FDA INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE M4: COMMON TECHNICAL DOCUMENT MODULES IIA, IIB NONCLINICAL MODULE III, QUALITY MODULES IV, NONCLINICAL MODULE V, EFFICACY
2953FDA International Conference on Harmonisation; Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability
2954FDA International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials; Availability
2955FDA International Conference on Harmonisation; Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Availability
2966Eudralex Volume 8 - Maximum residue limits - Veterinary Medicinal Products
2970FDA Q10 PHARMACEUTICAL QUALITY SYSTEM
3081Eudralex Volume 9 2001/82/EC on the Community code relating to veterinary medicinal products
3082Eudralex Volume 9 Volume 9b - Pharmacovigilance for Medicinal Products for Veterinary Use
3097Change Control Process for European eSubmission Standards - v2.1 (May 2011)
3099Eudralex Volume 2C CMDh BEST PRACTICE GUIDE ON THE PROCESSING OF RENEWALS IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES
3100Eudralex Volume 2C Guideline on the “2nd step”, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s).
3101Eudralex Volume 2C Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7): Annex
3116FDA Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
3117Eudralex Volume 3 GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES
3118Eudralex Volume 3 GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER
3119Eudralex Volume 3 GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS
3120Eudralex Volume 3 GUIDELINE ON DEVELOPMENT AND MANUFACTURE OF LENTIVIRAL VECTORS
3121Eudralex Volume 3 NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE
3123Eudralex Volume 3 NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS
3124Eudralex Volume 3 NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
3125Eudralex Volume 3 CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES
3128Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY
3131Eudralex Volume 3 USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE
3132Eudralex Volume 3 PRODUCTION AND QUALITY CONTROL OF CYTOKINE PRODUCTS DERIVED BY BIOTECHNOLOGICAL PROCESSES
3133Eudralex Volume 3 NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS (CPMP/ICH/365/96)
3134Eudralex Volume 3 TESTS ON SAMPLES OF BIOLOGICAL ORIGIN
3135Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
3136Eudralex Volume 3 GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
3137Eudralex Volume 3 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
3139Eudralex Volume 3 NOTE FOR GUIDANCE ON PLASMA-DERIVED MEDICINAL PRODUCTS
3140Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
3141Eudralex Volume 3 ANNEXES TO GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
3142Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (ANTI-HIV) IN PLASMA POOLS
3143Eudralex Volume 3 GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) IN PLASMA POOLS
3145Eudralex Volume 3 GUIDELINE ON THE REQUIREMENTS FOR PLASMA MASTER FILE (PMF) CERTIFICATION
3146Eudralex Volume 3 GUIDELINE ON ASSESSING THE RISK FOR VIRUS TRANSMISSION – NEW CHAPTER 6 OF THE NOTE FOR GUIDANCE ON PLASMADERIVED MEDICINAL PRODUCTS
3147Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
3149Eudralex Volume 3 CPMP POSITION STATEMENT ON WEST NILE VIRUS AND PLASMA-DERIVED MEDICINAL PRODUCTS
3150Eudralex Volume 3 CPMP POSITION STATEMENT NON-REMUNERATED AND REMUNERATED DONORS: SAFETY AND SUPPLY OF PLASMA-DERIVED MEDICINAL PRODUCTS
3151Eudralex Volume 3 PLASMA-DERIVED MEDICINAL PRODUCTS: POSITION PAPER ON ALT TESTING
3152Eudralex Volume 3 GUIDELINE ON DOSSIER STRUCTURE AND CONTENT OF MARKETING AUTHORISATION APPLICATIONS FOR INFLUENZA VACCINES DERIVED FROM STRAINS WITH A PANDEMIC POTENTIAL FOR USE OUTSIDE OF THE CORE DOSSIER CONTEXT
3153Eudralex Volume 3 GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
3154Eudralex Volume 3 EXPLANATORY NOTE ON IMMUNOMODULATORS FOR THE GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
3155Eudralex Volume 3 GUIDELINE ON DOSSIER STRUCTURE AND CONTENT FOR PANDEMIC INFLUENZA VACCINE MARKETING AUTHORISATION APPLICATION
3156Eudralex Volume 3 GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE
3157Eudralex Volume 3 GUIDELINE ON REQUIREMENTS FOR VACCINE ANTIGEN MASTER FILE (VAMF) CERTIFICATION
3158Eudralex Volume 3 CPMP POSITION STATEMENT ON THE QUALITY OF WATER USED IN THE PRODUCTION OF VACCINES FOR PARENTERAL USE
3159Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A VACCINE ANTIGEN MASTER FILE (VAMF)
3160Eudralex Volume 3 CELL CULTURE INACTIVATED INFLUENZA VACCINES ANNEX TO NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES (CPMP/BWP/214/96)
3161Eudralex Volume 3 POINTS TO CONSIDER ON THE DEVELOPMENT OF LIVE ATTENUATED INFLUENZA VACCINES
3162Eudralex Volume 3 NOTE FOR GUIDANCE ON THE DEVELOPMENT OF VACCINA VIRUS BASED VACCINES AGAINST SMALLPOX
3163Eudralex Volume 3 POINTS TO CONSIDER ON THE REDUCTION, ELIMINATION OR SUBSTITUTION OF THIOMERSAL IN VACCINES
3164Eudralex Volume 3 Public Statement on the Evaluation of Bovine Spongiform Encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines
3165Eudralex Volume 3 NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES
3166Eudralex Volume 3 NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES
3167Eudralex Volume 3 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS
3168Eudralex Volume 2C Guidance on a new therapeutic indication for a well established substance (November 2007)
3169Eudralex Volume 3 DEVELOPMENT PHARMACEUTICS FOR BIOTECHNOLOGICAL AND BIOLOGICAL PRODUCTS (CPMP/BWP/328/99) ANNEX TO NOTE FOR GUIDANCE ON DEVELOPMENT PHARMACEUTICS (CPMP/QWP/155/96)
3170Eudralex Volume 3 GUIDELINE ON POTENCY LABELLING FOR INSULIN ANALOGUE CONTAINING PRODUCTS WITH PARTICULAR REFERENCE TO THE USE OF “INTERNATIONAL UNITS” OR “UNITS”
3171Eudralex Volume 2C Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007)
3172Eudralex Volume 3 CORE SPC FOR PANDEMIC INFLUENZA VACCINES
3173GUIDELINE ON PHARMACEUTICAL ASPECTS OF THE PRODUCT INFORMATION FOR HUMAN VACCINES
3174Eudralex Volume 3 NOTE FOR GUIDANCE ON THE WARNING ON TRANSMISSIBLE AGENTS IN SUMMARY OF PRODUCT CHARACTERISTICS (SPCs) AND PACKAGE LEAFLETS FOR PLASMA-DERIVED MEDICINAL PRODUCTS
3175Eudralex Volume 3 GUIDANCE ON THE DESCRIPTION OF COMPOSITION OF PEGYLATED (CONJGATED) PROTEINS IN THE SPC
3176Eudralex Volume 3 GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
3177Eudralex Volume 3 NOTE FOR GUIDANCE ON THE USE OF BOVINE SERUM IN THE MANUFACTURE OF HUMAN BIOLOGICAL MEDICINAL PRODUCTS
3178Eudralex Volume 3 POSITION PAPER ON VIRAL SAFETY OF ORAL POLIOVIRUS VACCINE (OPV)
3179Eudralex Volume 3 NOTE FOR GUIDANCE ON Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
3180Eudralex Volume 3 NOTE FOR GUIDANCE ON VIRUS VALIDATION STUDIES: THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES
3181Eudralex Volume 3 FIRST CASES OF BSE IN USA AND CANADA: RISK ASSESSMENT OF RUMINANT MATERIALS ORIGINATING FROM USA AND CANADA
3182Eudralex Volume 3 NOTE FOR GUIDANCE ON GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS AMENDMENTS TO SECTIONS 6.2 AND 6.3
3183Eudralex Volume 3 NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS (EMEA/410/01 REV. 3) (2011/C 73/01)
3184Eudralex Volume 3 POSITION PAPER ON RE-ESTABLISHMENT OF WORKING SEEDS AND WORKING CELL BANKS USING TSE COMPLIANT MATERIALS
3185Eudralex Volume 3 PUBLIC REPORT RISK AND REGULATORY ASSESSMENT OF LACTOSE AND OTHER PRODUCTS PREPARED USING CALF RENNET
3186Eudralex Volume 3 JOINT CPMP/CVMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS - EXPLANATORY NOTE FOR MEDICINAL PRODUCTS FOR HUMAN USE IN THE SCOPE OF THE GUIDELINE
3187Eudralex Volume 3 QUESTIONS AND ANSWERS ON BOVINE SPONGIFORM ENCEPHALOPATHIES (BSE) AND VACCINES
3188Eudralex Volume 3 PUBLIC STATEMENT ON THE EVLAUATION OF SPONGIFORM ENCEPHALOPATHIES (BSE)-RISK VIA THE USE OF MATERIALS OF BOVINE ORIGIN IN OR DURING THE MANUFACTURE OF VACCINES
3189Eudralex Volume 3 GELATIN FOR USE IN PHARMACEUTICALS: EXPLANATORY NOTE (13 DECEMBER 2000) ON THE MANUFACTURE OF GELATIN IN RELATIONSHIP TO THE CPMP NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPAHTY AGENTS VIA MEDICINAL PRODUCTS (CPMP/BWP/1230/98 REV 1)
3190Eudralex Volume 3 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION STATEMENT ON POLYSORBATE 80
3191Eudralex Volume 3 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON PRODUCTION OF TALLOW DERIVATIVES FOR USE IN PHARMACEUTICALS
3192Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
3193Eudralex Volume 3 CHMP POSITION STATEMENT ON CREUTZFELDT-JACOB DISEASE and PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS
3194Eudralex Volume 3 GUIDELINE ON ENVIRONMENTAL RISK ASSESSMENTS FOR MEDICINAL PRODUCTS CONSISTING OF, OR CONTAINING, GENETICALLY MODIFIED ORGANISMS (GMOs)
3195EU GMP Inspection report - Community format
3196FDA Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
3197FDA Guidance for Industry “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV
3198FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE
3199FDA Guidance for Industry Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
3200FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3201FDA Guidance for Industry and FDA Review Staff Collection of Platelets by Automated Methods
3203FDA Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
3204FDA FEDERAL REGISTER 21 CFR Part 866 [Docket No. 2007N–0294] Medical Devices: Immunology and Microbiology Devices: Classification of In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay
3205FDA Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
3207FDA Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
3208FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3209FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule
3212FDA Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide
3213FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
3214FDA FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule
3215FDA Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
3235NOTICE TO APPLICANTS Volume 6A VETERINARY MEDICINAL PRODUCTS General Information
3236NOTICE TO APPLICANTS Volume 6C GUIDELINE ON THE PACKAGING INFORMATION OF VETERINARY MEDICINAL PRODUCTS AUTHORISED BY THE COMMUNITY
3238FDA Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
3240FDA Marketed Unapproved Drugs
3241FDA PET Drug Products - CGMP / Small Entities
3242FDA Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
3285Eudralex Volume 10 Guidance for the communication on GCP inspections and findings

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