Nr.	Titel
2717	IPEC Good Manufacturing Practices Audit Guideline for Distributors of Bulk Pharmaceutical Excipients
2722	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-7) Part I (Sept 2007)
2723	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-7) Part II (Sept 2007)
2724	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-7) Annexes (Sept 2007)
2740	Computerized Systems Used in Clinical Investigations
2748	Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol
2749	The international Pharmacopoeia - related substances tests: dosage form monographs guidance notes
2750	General guidelines for the establishment, maintenance and distribution of chemical reference substances
2751	Guidance on variations to a prequalified product dosser
2762	Guidance 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
2764	Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs
2765	Guidance 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(Electronic Based Testing for the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)DRAFT GUIDANCE
2766	Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
2767	Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
2768	Guidance for Industry: Bar Code Label Requirements, Questions and Answers
2769	Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
2770	Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin G (IgG) Antibodies
2771	Guidance 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of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products” DRAFT GUIDANCE
2772	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
2773	Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency DRAFT GUIDANCE
2774	Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods DRAFT GUIDANCE
2775	Guidance 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
2776	Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection
2777	Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2778	Guidance 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
2779	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)
2780	Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes DRAFT GUIDANCE
2781	Guidance 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
2782	Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
2783	Guidance for Industry:Notifying FDA of Fatalities Related to Blood Collection or Transfusion
2784	Guidance 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
2785	Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered Questionnaires
2786	Guidance for Industry Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis DRAFT GUIDANCE
2787	Guidance 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
2788	Guidance for Industry A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations DRAFT GUIDANCE
2789	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
2790	General Principles of Software Validation; Final Guidance for Industry and FDA Staff
2791	Guidance for Industry Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax
2792	Guidance for Industry Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls DRAFT GUIDANCE
2793	Guidance for Industry Variances for Blood Collection from Individuals with Hereditary Hemochromatosis
2794	Guidance for Industry Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
2795	Guidance for FDA Reviewers Premarket Notification Submissions for Blood and Plasma Warmers
2796	Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
2797	Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
2798	Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
2799	Guidance for Industry CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained from an Outside Supplier
2800	Guidance for Industry Monoclonal Antibodies Used as Reagents in Drug Manufacturing
2801	Guidance for Industry Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
2802	Guidance for Industry Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion DRAFT – NOT FOR IMPLEMENTATION
2803	Guidance for Industry Use of Sterile Connecting Devices in Blood Bank Practices
2804	Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
2805	Guidance for Industry Recommendations for Donor Questioning Regarding Possible Exposure to Malaria
2806	Guidance 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
2807	Guidance For Industry Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti- HCV) DRAFT GUIDANCE
2808	Guidance for Industry Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
2809	Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products DRAFT GUIDANCE
2810	Guidance 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”
2811	Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product
2812	Guidance 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
2813	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
2814	Guidance for Industry Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing
2815	Guidance for Industry The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use
2816	Guidance for Industry Donor Screening for Antibodies to HTLV-II
2817	GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS
2818	DRAFT POINTS TO CONSIDER IN THE DESIGN AND IMPLEMENTATION OF FIELD TRIALS FOR BLOOD GROUPING REAGENTS AND ANTI-HUMAN GLOBULIN
2819	DRAFT RECOMMENDED METHODS FOR BLOOD GROUPING REAGENTS EVALUATION
2820	DRAFT RECOMMENDED METHODS FOR EVALUATING POTENCY, SPECIFICITY, AND REACTIVITY OF ANTI-HUMAN GLOBULIN
2821	Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)
2822	Draft of "Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to (1989)"
2823	Revised Guideline for the Collection of Platelets, Pheresis
2824	Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and Animal Parenteral Drugs, Biological Products and Medical Devices
2825	Guideline for the Uniform Labeling of Blood and Blood Components
2827	FEDERAL REGISTER Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice
2828	Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage DRAFT GUIDANCE
2829	Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
2830	Guidance for Industry Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events
2831	Guidance 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
2832	Guidance for FDA Review Staff and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) DRAFT GUIDANCE
2833	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
2834	Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy
2835	Draft Guidance for Industry, Clinical Laboratories, and FDA Staff In Vitro Diagnostic Multivariate Index Assays DRAFT GUIDANCE
2836	Guidance for Industry and FDA Staff Bundling Multiple Devices or Multiple Indications in a Single Submission
2837	Draft Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision-Making Process
2838	Draft Guidance for Industry and FDA Staff Annual Reports for Approved Premarket Approval Applications (PMA)
2839	Guidance for Industry and FDA Staff Real-Time Premarket Approval Application (PMA) Supplements
2840	FEDERAL 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
2841	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
2842	Guidance for Industry and FDA Staff Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
2843	Guidance for Industry and FDA Staff FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
2844	Guidance for Industry and FDA Staff Expedited Review of Premarket Submissions for Devices
2845	Guidance for Industry and FDA Staff Premarket Approval Application Modular Review
2846	FEDERAL REGISTER Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay
2847	Guidance for Industry and FDA Staff FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment
2848	Guidance for Industry and FDA Staff Premarket Assessment of Pediatric Medical Devices
2849	Guidance for Industry and FDA Staff Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
2850	Guidance for Industry and FDA Staff Premarket Approval Application Filing Review
2851	Guidance for Industry, FDA Staff, and Third Parties Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria
2852	Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
2853	The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
2854	Guidance for Industry A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations DRAFT GUIDANCE
2855	General Principles of Software Validation; Final Guidance for Industry and FDA Staff
2856	Guidance for Industry Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls DRAFT GUIDANCE
2857	Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
2858	Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components
2859	Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
2860	Guidance for Industry Use of Sterile Connecting Devices in Blood Bank Practices
2861	Guidance for Industry Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) DRAFT GUIDANCE
2862	FEDERAL REGISTER Food and Drug Administration Modernization Act of 1997; List of Documents Issued by the Food and Drug Administration That Apply to Medical Devices Regulated by the Center for Biologics Evaluation and Research
2863	Guidance for Industry Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
2864	FEDERAL REGISTER Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
2865	FEDERAL REGISTER Natural Rubber-Containing Medical Devices; User Labeling
2867	Guidance for Industry Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
2868	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
2869	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
2870	PHS GUIDELINE ON INFECTIOUS DISEASE ISSUES IN XENOTRANSPLANTATION
2871	FEDERAL REGISTER ‘‘PHS Guideline on Infectious Disease Issues in Xenotransplantation;’’ Availability
2872	FEDERAL REGISTER Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation
2873	Guidance For Industry Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans
2874	Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
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	Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials DRAFT GUIDANCE
2891	Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications DRAFT GUIDANCE
2892	Guidance for Industry FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information
2893	FEDERAL REGISTER Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses
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)
2899	GUIDANCE FOR INDUSTRY FOR THE EVALUATION OF COMBINATION VACCINES FOR PREVENTABLE DISEASES: PRODUCTION, TESTING AND CLINICAL STUDIES
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	FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Opportunity for Public Comment
2918	FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; delay of effective date
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	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
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	FEDERAL REGISTER Human Tissue Intended for Transplantation
2928	FEDERAL REGISTER Public Hearing: Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Implantation for Structural Repair or Reconstruction
2929	FEDERAL REGISTER Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice
2930	Guidance for Industry INDs — Approaches to Complying with CGMP During Phase 1 Draft Guidance
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
2956	ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
2957	Guideline in Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products