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2635M2 eCTD Specification Questions and Answers and Change Requests
2636M3 Nonclinical Safety Studies for the Conduct of Human Clinical trials for Pharmaceuticals
2637M4: Granularity Document - Annex to M4: Organization of the CTD
2638M4: The CTD - General Questions and Answers
2639M4Q: The CTD - Quality
2640M4: The CTD - Quality Questions and Answers/Location Issues
2641M4E: The CTD - Efficacy
2642M4: The CTD - Efficacy Questions and Answers
2643M4S: The CTD - Safety
2644M4S: The CTD - Safety Appendices
2645M4: The CTD - Safety Questions and Answers
2647Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
2648Labeling OTC Human Drug Products
2659EC/1901/2006: Regulation (EC) No 1901/2006 ofor paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
2660EC/1902/2006: Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006amending Regulation 1901/2006 on medicinal products for paediatric use
2668Detailed guidance on the European clinical trials database (EUDRACT Database)
2669Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use
26712010/C 82/01: Communication from the Commission —Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1)
2673Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use
2674Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module)
2676ANNEX 13 - Good Manufacturing Practice for the manufacture of investigational medicinal products
2677Detailed guidelines on good clinical practice specific to advanced therapy medicinal products
2678GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS
2681RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING
2682List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02
2683Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
2685DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
2686COMMISSION DIRECTIVE 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
2687COMMISSION DIRECTIVE 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
2722Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Part I (Sept 2009)
2723Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Part II (Sept 2009)
2724Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Annexes (Sept 2009)
2740Computerized Systems Used in Clinical Investigations
2748Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
2749The international Pharmacopoeia - related substances tests: dosage form monographs guidance notes
2750General guidelines for the establishment, maintenance and distribution of chemical reference substances
2751Guidance on variations to a prequalified product dosser
2762Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
2764Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
2765Guidance for Industry: “Computer Crossmatch” (Electronic Based Testing for the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)DRAFT GUIDANCE
2766Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
2767Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
2768Guidance for Industry: Bar Code Label Requirements, Questions and Answers
2769Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
2770Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies
2771Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” DRAFT GUIDANCE
2772Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
2773Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency DRAFT GUIDANCE
2775Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry DRAFT GUIDANCE
2776Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
2777Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2778Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle DRAFT GUIDANCE
2779Guidance 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)
2780Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes DRAFT GUIDANCE
2781Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donations of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
2782Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
2783Guidance for Industry:Notifying FDA of Fatalities Related to Blood Collection or Transfusion
2784Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
2785Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires
2786Guidance for Industry Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis DRAFT GUIDANCE
2787Guidance for Industry Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients
2789Guidance 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
2791Guidance for Industry Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax
2793Guidance for Industry Variances for Blood Collection from Individuals with Hereditary Hemochromatosis
2794Guidance for Industry Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
2795Guidance for FDA Reviewers Premarket Notification Submissions for Blood and Plasma Warmers
2796Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
2797Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
2798Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
2800Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing
2801Guidance for Industry Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
2802Guidance for Industry Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion DRAFT – NOT FOR IMPLEMENTATION
2803Guidance for Industry Use of Sterile Connecting Devices in Blood Bank Practices
2804Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
2805Guidance for Industry Recommendations for Donor Questioning Regarding Possible Exposure to Malaria
2806Guidance for Industry In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
2807Guidance 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
2808Guidance for Industry Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
2809Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products DRAFT GUIDANCE
2810Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use”
2811Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product
2812Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma- Derived Biological Products, Animal Plasma or Serum-Derived Products
2813ORA Quality Manual
2814Guidance for Industry Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing
2817GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS
2818DRAFT POINTS TO CONSIDER IN THE DESIGN AND IMPLEMENTATION OF FIELD TRIALS FOR BLOOD GROUPING REAGENTS AND ANTI-HUMAN GLOBULIN
2819DRAFT RECOMMENDED METHODS FOR BLOOD GROUPING REAGENTS EVALUATION
2820DRAFT RECOMMENDED METHODS FOR EVALUATING POTENCY, SPECIFICITY, AND REACTIVITY OF ANTI-HUMAN GLOBULIN
2821Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)
2825Guideline for the Uniform Labeling of Blood and Blood Components
2828Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage DRAFT GUIDANCE
2829Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2830Guidance for Industry Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events
2831Guidance for Industry Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors
2834Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy
2835Draft Guidance for Industry, Clinical Laboratories, and FDA Staff In Vitro Diagnostic Multivariate Index Assays DRAFT GUIDANCE
2839Medicinal Gases: draft guideline (CPMP/QWP/1719/00 Rev 1)
2840FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
2841FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Reclassification of Automated Blood Cell Separator Device Operating by Filtration Principle from Class III to Class II
2842Guidance for Industry and FDA Staff Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
2843draft: GUIDELINE ON THE SPECIFICATION LIMITS FOR RESIDUES OF METAL CATALYSTS
2844Adopted Guideline (Radiopharmaceuticals)
2845Draft Guideline (Radiopharmaceuticals)
2846FEDERAL REGISTER Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay
2847Concept paper
2848Human cell-based medicinal products
2849Concept Paper for the revision of Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products
2850Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells
2851The replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products
2852Concept Paper: Revision of the Note for guidance on Plasma-Derived Medicinal Products
2853Draft : Revision of CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products
2855Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture
2857Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
2858Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
2859Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
2862COMPLIANCE POLICY GUIDE Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)
2864COMPLIANCE POLICY GUIDES - Foreword
2867Guidance for Industry Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
2869Guidance 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
2870PHS GUIDELINE ON INFECTIOUS DISEASE ISSUES IN XENOTRANSPLANTATION
2873Guidance For Industry Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans
2874Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
2875COMPLIANCE PROGRAM GUIDANCE MANUAL Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002
2876Compliance Program Chapter 41 - Therapeutic Products Inspection of Tissue Establishments 7341.002A
2877Compliance Program Guidance Manual Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001
2878Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002
2879COMPLIANCE PROGRAM GUIDANCE MANUAL Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) 7342.007 Addendum
2880Compliance Program Chapter 42 - Blood and Blood Products Inspection of Licensed Viral Marker Test Kits 7342.008
2881Compliance Program Guidance Manual Chapter – 45 Biological Drug Products Inspection of Biological Drug Products (CBER) 7345.848
2882Guidance for Industry Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
2883Guidance for Industry Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
2884Guidance 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
2886Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
2888FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
2889FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order
2890COMPLIANCE POLICY GUIDES - Introduction
2891COMPLIANCE POLICY GUIDE Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (CPG 7150.13)
2892Guidance for Industry FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
2893COMPLIANCE POLICY GUIDE Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16) Page 5
2894Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE
2896Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications
2897Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product
2898Guidance for Industry How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)
2900Guidance for Industry Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs) DRAFT GUIDANCE
2901Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage DRAFT GUIDANCE
2902FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
2903FEDERAL REGISTER Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
2904Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2905Guidance for Industry Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
2906FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
2907Guidance 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
2908Guidance for Industry Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies DRAFT GUIDANCE
2909Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update
2910Guidance for Industry Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements
2911FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction
2912FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule and Notice
2913Guidance for Industry MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2914FEDERAL REGISTER Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue- Based Product Establishments; Inspection and Enforcement; Final Rule
2915Guidance 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)
2916FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction
2917COMPLIANCE POLICY GUIDE Sec. 140.500 Metric Declarations of Quantity of Contents on Product Labels (CPG 7150.17)
2918COMPLIANCE POLICY GUIDE Sec. 300.100 Inspection of Manufacturers of Device Components (CPG 7124.15)
2919FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule
2920Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) DRAFT GUIDANCE
2921FEDERAL REGISTER Combination Products Containing Live Cellular Components; Public Hearing
2922Guidance for Industry Validation of Procedures for Processing of Human Tissues Intended for Transplantation
2923Human Cells or Tissues Intended for Transplant Into a Human Recipient That Have Ex-vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs Letter
2924COMPLIANCE POLICY GUIDE Sec. 400.100 Drugs, Human - Failure to Register (CPG 7132.07)
2925Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
2926Guidance for Industry Screening and Testing of Donors of Human Tissue Intended for Transplantation
2927COMPLIANCE POLICY GUIDE Sec. 400.200 Consistent Application of CGMP Determinations (CPG 7132.12)
2928COMPLIANCE POLICY GUIDE Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)
2929COMPLIANCE POLICY GUIDE Sec. 400.900 Class I Recalls of Prescription Drugs (CPG 7132.01)
2930Guidance for Industry CGMP for Phase 1 Investigational Drugs
2931Guidance for Industry Pharmacogenomic Data Submissions
2933Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments
2934Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications
2935Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies
2936Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions DRAFT GUIDANCE
2938Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) DRAFT GUIDANCE
2939Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications
2941Guidance for Industry Providing Regulatory Submissions to CBER in Electronic Format — Investigational New Drug Applications (INDs)
2942Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees DRAFT GUIDANCE
2943Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information
2944Guidance for Industry Acceptance of Foreign Clinical Studies
2945Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
2946Guidance for Industry Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
2947Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products
2949Guidance for Industry Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
2951Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products
2952INTERNATIONAL 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
2953International Conference on Harmonisation; Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability
2954International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials; Availability
2955International Conference on Harmonisation; Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Availability
2958Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Tradtionals Herbal Medicinal Products in the SPC
2966Eudralex Volume 8 - Maximum residue limits - Veterinary Medicinal Products
2970Q10 PHARMACEUTICAL QUALITY SYSTEM
3081Volume 9a - Pharmacovigilance for Medicinal Products for Human Use
3082Volume 9b - Pharmacovigilance for Medicinal Products for Veterinary Use
3083Notice to Applicants, Volume 2B, incorporating the Common Technical Document (CTD)(May 2008)