Nr.	Titel
2875	COMPLIANCE PROGRAM GUIDANCE MANUAL Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002
2876	Compliance Program Chapter 41 - Therapeutic Products Inspection of Tissue Establishments 7341.002A
2877	Compliance Program Guidance Manual Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001
2878	Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002
2879	COMPLIANCE PROGRAM GUIDANCE MANUAL Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) 7342.007 Addendum
2880	Compliance Program Chapter 42 - Blood and Blood Products Inspection of Licensed Viral Marker Test Kits 7342.008
2881	Compliance Program Guidance Manual Chapter – 45 Biological Drug Products Inspection of Biological Drug Products (CBER) 7345.848
2882	Guidance for Industry Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
2883	Guidance for Industry Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
2884	Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases DRAFT GUIDANCE
2885	Guidance for Industry Development of Preventive HIV Vaccines for Use in Pediatric Populations
2886	Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
2888	FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
2889	FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order
2890	COMPLIANCE POLICY GUIDES - Introduction
2891	COMPLIANCE POLICY GUIDE Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (CPG 7150.13)
2892	Guidance for Industry FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
2893	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
2894	Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE
2895	Guidance for Reviewers Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
2896	Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
2897	Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product
2898	Guidance for Industry How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)
2900	Guidance for Industry Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs) DRAFT GUIDANCE
2901	Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage DRAFT GUIDANCE
2902	FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
2903	FEDERAL REGISTER Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
2904	Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2905	Guidance for Industry Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
2906	FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
2907	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
2908	Guidance for Industry Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies DRAFT GUIDANCE
2909	Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
2910	Guidance for Industry Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements
2911	FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction
2912	FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule and Notice
2913	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)
2914	FEDERAL REGISTER Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue- Based Product Establishments; Inspection and Enforcement; Final Rule
2915	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)
2916	FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction
2917	COMPLIANCE POLICY GUIDE Sec. 140.500 Metric Declarations of Quantity of Contents on Product Labels (CPG 7150.17)
2918	COMPLIANCE POLICY GUIDE Sec. 300.100 Inspection of Manufacturers of Device Components (CPG 7124.15)
2919	FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule
2920	Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) DRAFT GUIDANCE
2921	FEDERAL REGISTER Combination Products Containing Live Cellular Components; Public Hearing
2922	Guidance for Industry Validation of Procedures for Processing of Human Tissues Intended for Transplantation
2923	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
2924	COMPLIANCE POLICY GUIDE Sec. 400.100 Drugs, Human - Failure to Register (CPG 7132.07)
2925	Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
2926	Guidance for Industry Screening and Testing of Donors of Human Tissue Intended for Transplantation
2927	COMPLIANCE POLICY GUIDE Sec. 400.200 Consistent Application of CGMP Determinations (CPG 7132.12)
2928	COMPLIANCE POLICY GUIDE Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)
2929	COMPLIANCE POLICY GUIDE Sec. 400.900 Class I Recalls of Prescription Drugs (CPG 7132.01)
2930	Guidance for Industry CGMP for Phase 1 Investigational Drugs
2931	Guidance for Industry Pharmacogenomic Data Submissions
2933	Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments
2934	Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications
2935	Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies
2936	Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions DRAFT GUIDANCE
2937	Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer
2938	Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) DRAFT GUIDANCE
2939	Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
2940	Guidance for Industry Special Protocol Assessment
2941	Guidance for Industry Providing Regulatory Submissions to CBER in Electronic Format — Investigational New Drug Applications (INDs)
2942	Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees DRAFT GUIDANCE
2943	Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information
2944	Guidance for Industry Acceptance of Foreign Clinical Studies
2945	Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
2946	Guidance for Industry Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
2947	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
2948	Guidance for Industry Formal Dispute Resolution: Appeals Above the Division Level
2949	Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
2950	Guidance for Industry Fast Track Drug Development Programs — Designation, Development, and Application Review
2951	Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products
2952	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
2953	International Conference on Harmonisation; Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability
2954	International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials; Availability
2955	International Conference on Harmonisation; Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Availability
2958	Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Tradtionals Herbal Medicinal Products in the SPC
2966	Eudralex Volume 8 - Maximum residue limits - Veterinary Medicinal Products
2970	Q10 PHARMACEUTICAL QUALITY SYSTEM
3081	Volume 9a - Pharmacovigilance for Medicinal Products for Human Use
3082	Volume 9b - Pharmacovigilance for Medicinal Products for Veterinary Use
3083	Notice to Applicants, Volume 2B, incorporating the Common Technical Document (CTD)(May 2008)
3084	Application Form: Module 1.2 Application form - updated version - May 2008
3085	Module 1.2 Application form (May 2008)
3086	Module 1.2 Homeopathic application form (December 2005)
3087	User guide for the application form (March 2005)
3088	Notice to Applicants, Volume 2B - Questions and Answers (February 2008)
3090	Notice to Applicants, Volume 2B - Electronic Common Technical Document (eCTD)
3095	Guidance on paper submission with eCTD version 1.0 (February 2006)
3097	Change Control Process for European eCTD Standards - v1.1 (December 2006)
3099	Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures (Revision 4, February 2008)
3100	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).
3101	Annex
3116	Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
3117	GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES
3118	GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER
3119	GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS
3120	GUIDELINE ON DEVELOPMENT AND MANUFACTURE OF LENTIVIRAL VECTORS
3121	NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE
3122	POINTS TO CONSIDER ON THE MANUFACTURE AND QUALITY CONTROL OF HUMAN SOMATIC CELL THERAPY MEDICINAL PRODUCTS
3123	NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS
3124	NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
3125	CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES
3127	NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLO-GICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELL LINES USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN PRODUCTS
3128	PRODUCTION AND QUALITY CONTROL OF MEDICINAL PRODUCTS DERIVED BY RECOMBINANT DNA TECHNOLOGY
3131	USE OF TRANSGENIC ANIMALS IN THE MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE
3132	PRODUCTION AND QUALITY CONTROL OF CYTOKINE PRODUCTS DERIVED BY BIOTECHNOLOGICAL PROCESSES
3133	NOTE FOR GUIDANCE ON SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
3134	TESTS ON SAMPLES OF BIOLOGICAL ORIGIN
3135	GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
3136	GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
3137	NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS
3138	GUIDELINE ON COMPARABILITY OF MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROETINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
3139	NOTE FOR GUIDANCE ON PLASMA-DERIVED MEDICINAL PRODUCTS
3140	GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
3141	ANNEXES TO GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
3142	GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (ANTI-HIV) IN PLASMA POOLS
3143	GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) IN PLASMA POOLS
3145	GUIDELINE ON THE REQUIREMENTS FOR PLASMA MASTER FILE (PMF) CERTIFICATION
3146	GUIDELINE ON ASSESSING THE RISK FOR VIRUS TRANSMISSION – NEW CHAPTER 6 OF THE NOTE FOR GUIDANCE ON PLASMADERIVED MEDICINAL PRODUCTS
3147	GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
3149	CPMP POSITION STATEMENT ON WEST NILE VIRUS AND PLASMA-DERIVED MEDICINAL PRODUCTS
3150	CPMP POSITION STATEMENT NON-REMUNERATED AND REMUNERATED DONORS: SAFETY AND SUPPLY OF PLASMA-DERIVED MEDICINAL PRODUCTS
3151	PLASMA-DERIVED MEDICINAL PRODUCTS: POSITION PAPER ON ALT TESTING
3152	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
3153	GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
3154	EXPLANATORY NOTE ON IMMUNOMODULATORS FOR THE GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE
3155	GUIDELINE ON DOSSIER STRUCTURE AND CONTENT FOR PANDEMIC INFLUENZA VACCINE MARKETING AUTHORISATION APPLICATION
3156	GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE
3157	GUIDELINE ON REQUIREMENTS FOR VACCINE ANTIGEN MASTER FILE (VAMF) CERTIFICATION
3158	CPMP POSITION STATEMENT ON THE QUALITY OF WATER USED IN THE PRODUCTION OF VACCINES FOR PARENTERAL USE
3159	GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A VACCINE ANTIGEN MASTER FILE (VAMF)
3160	CELL CULTURE INACTIVATED INFLUENZA VACCINES ANNEX TO NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES (CPMP/BWP/214/96)
3161	POINTS TO CONSIDER ON THE DEVELOPMENT OF LIVE ATTENUATED INFLUENZA VACCINES
3162	NOTE FOR GUIDANCE ON THE DEVELOPMENT OF VACCINA VIRUS BASED VACCINES AGAINST SMALLPOX
3163	POINTS TO CONSIDER ON THE REDUCTION, ELIMINATION OR SUBSTITUTION OF THIOMERSAL IN VACCINES
3164	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
3165	NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES
3166	NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES
3167	QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS
3168	Guidance on a new therapeutic indication for a well established substance (November 2007)
3169	DEVELOPMENT PHARMACEUTICS FOR BIOTECHNOLOGICAL AND BIOLOGICAL PRODUCTS (CPMP/BWP/328/99) ANNEX TO NOTE FOR GUIDANCE ON DEVELOPMENT PHARMACEUTICS (CPMP/QWP/155/96)
3170	GUIDELINE ON POTENCY LABELLING FOR INSULIN ANALOGUE CONTAINING PRODUCTS WITH PARTICULAR REFERENCE TO THE USE OF “INTERNATIONAL UNITS” OR “UNITS”
3171	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)
3172	CORE SPC FOR PANDEMIC INFLUENZA VACCINES
3173	GUIDELINE ON PHARMACEUTICAL ASPECTS OF THE PRODUCT INFORMATION FOR HUMAN VACCINES
3174	NOTE FOR GUIDANCE ON THE WARNING ON TRANSMISSIBLE AGENTS IN SUMMARY OF PRODUCT CHARACTERISTICS (SPCs) AND PACKAGE LEAFLETS FOR PLASMA-DERIVED MEDICINAL PRODUCTS
3175	GUIDANCE ON THE DESCRIPTION OF COMPOSITION OF PEGYLATED (CONJGATED) PROTEINS IN THE SPC
3176	GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
3177	NOTE FOR GUIDANCE ON THE USE OF BOVINE SERUM IN THE MANUFACTURE OF HUMAN BIOLOGICAL MEDICINAL PRODUCTS
3178	POSITION PAPER ON VIRAL SAFETY OF ORAL POLIOVIRUS VACCINE (OPV)
3179	NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLOGICAL PRODUCTS: VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVE
3180	NOTE FOR GUIDANCE ON VIRUS VALIDATION STUDIES: THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES
3181	FIRST CASES OF BSE IN USA AND CANADA: RISK ASSESSMENT OF RUMINANT MATERIALS ORIGINATING FROM USA AND CANADA
3182	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
3183	NOTE FOR GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS (EMEA/410/01 REV. 2 - OCTOBER 2003) ADOPTED BY THE COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) AND BY THE COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)
3184	POSITION PAPER ON RE-ESTABLISHMENT OF WORKING SEEDS AND WORKING CELL BANKS USING TSE COMPLIANT MATERIALS
3185	PUBLIC REPORT RISK AND REGULATORY ASSESSMENT OF LACTOSE AND OTHER PRODUCTS PREPARED USING CALF RENNET
3186	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
3187	QUESTIONS AND ANSWERS ON BOVINE SPONGIFORM ENCEPHALOPATHIES (BSE) AND VACCINES
3188	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
3189	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)
3190	COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION STATEMENT ON POLYSORBATE 80
3191	COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON PRODUCTION OF TALLOW DERIVATIVES FOR USE IN PHARMACEUTICALS
3192	GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
3193	CHMP POSITION STATEMENT ON CREUTZFELDT-JACOB DISEASE and PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS
3194	GUIDELINE ON ENVIRONMENTAL RISK ASSESSMENTS FOR MEDICINAL PRODUCTS CONSISTING OF, OR CONTAINING, GENETICALLY MODIFIED ORGANISMS (GMOs)
3195	GMP Inspection report - Community format
3196	Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
3197	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
3198	Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE
3199	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
3200	Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3201	Guidance for Industry and FDA Review Staff Collection of Platelets by Automated Methods
3203	Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
3204	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
3205	Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
3206	Guidance for Industry, FDA, and Foreign Governments: FY 2009 Medical Device User Fee Small Business Qualification and Certification
3207	Draft Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions
3208	Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
3209	FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule
3210	Guidance for Industry and FDA Staff Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
3211	Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
3212	Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide
3213	Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
3214	FEDERAL REGISTER: Revision of the Requirements for Live Vaccine Processing; Direct Final Rule
3215	Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
3235	NOTICE TO APPLICANTS Volume 6A VETERINARY MEDICINAL PRODUCTS General Information
3236	NOTICE TO APPLICANTS Volume 6C GUIDELINE ON THE PACKAGING INFORMATION OF VETERINARY MEDICINAL PRODUCTS AUTHORISED BY THE COMMUNITY
3237	Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
3238	Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
3240	Marketed Unapproved Drugs
3241	PET Drug Products - CGMP
3242	Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
3246	EC/312/2008 Commission Regulation (EC) No 312/2008 of 3 April 2008 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
3247	Annex 20: Quality Risk Management
3284	GUIDANCE FOR EXCHANGE OF GCP INSPECTION REPORTS ACCORDING TO DIRECTIVE 2001/20/EC ARTICLE 15 (2)
3285	GUIDANCE FOR THE COMMUNICATION ON GOOD CLINICAL PRACTICE INSPECTIONS AND FINDINGS