Nr.	Titel
2303	CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff
2312	Part II of the EU Guidelines to GMP: Basic Requirements for Active Substances used as Starting Materials
2313	SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING (HVAC) SYSTEMS FOR NON-STERILE DOSAGE FORMS (October 2005)
2314	FIGURES TO SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING (HVAC) SYSTEMS FOR NON-STERILE DOSAGE FORMS
2329	Q4B Annex 1 Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)
2330	Zweites Gesetz zur Anderung des Medizinproduktegesetzes (2. MPG-AndG).
2331	Gesetz zur Änderung medizinprodukterechtlicher und anderer Vorschriften
2333	2005/28/EC - Commission Directive 2005/28/EC of 8 April 2005 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
2334	EC/2743/98 - Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 345, 19/12/1998 P. 3 - 8 CONSLEG - 95R0297 - 19/12/1998 - 15 p.).
2335	EC/494/2003 - Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products
2336	EC/507/2006 - Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 92, 30/3/2006 p. 6 - 9).
2337	2006/C 133/05 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)
2349	EC/1905/2005 Council Regulation (EC) No 1905/2005, of 14 November 2005, amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency (Official Journal L 340, 13/11/2005 p. 1 - 9)
2354	EC/1905/2005 Council Regulation (EC) No 1905/2005, of 14 November 2005, amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
2355	EC/2049/2005 Commission Regulation (EC) No 2049/2005, of 15 December 2005, laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises
2362	Verordnung zur Änderung medizinprodukterechtlicher Vorschriften
2363	Verordnung über das Errichten, Vertreiben und Anwenden von Medizinprodukten
2370	Annual Reports for Approved Premarket Approval Applications (PMA)
2507	MEDICINAL PRODUCTS ACT (THE DRUG LAW) - (ARZNEIMITTELGESETZ – AMG)of the FEDERAL REPUBLIC OF GERMANY
2509	Einleitung zum GMP-Leitfaden (Anlage 1 zur Bekanntmachung des BMG zu § 2 Nr. 3 der AMWHV)
2534	AIDE-MEMOIRE ON THE INSPECTION OF MEDICINAL GASES PI 025-2
2547	Guidance on Parametric Release (PIC/S PI 005-3)
2556	Leitfaden der Guten Herstellungspraxis, Teil I: Anlage 2 zur Bekanntmachung des Bundesministeriums für Gesundheit zu § 2 Nr. 3 der Arzneimittel- und Wirkstoffherstellungsverordnung vom 27. Oktober 2006
2557	Leitfaden der Guten Herstellungspraxis, Teil II: Grundlegende Anforderungen für Wirkstoffe zur Verwendung als Ausgangsstoffe
2560	Guide to Good Manufacturing Practices of preparation of medicinal products in healthcare establishments (PIC/S PE 010-3)
2561	Verordnung vom 18. Mai 2005 über die gute Laborpraxis (GLPV)
2562	Arzneimittel-Zulassungsverordnung, AMZV 26. November 2002 Änderung vom 22. Juni 2006
2563	Verordnung vom 22. Juni 2006 des Schweizerischen Heilmittelinstituts über die Zulassung von Komplementär- und Phytoarzneimitteln (KPAV)
2564	Verordnung vom 22. Juni 2006 betreffend die Liste der verschreibungspflichtigen Medizinprodukte (VLvM)
2565	Water for pharmaceutical use (WHO Technical Series 929)
2566	Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
2567	Validation
2568	Good distribution practice for pharmaceutical products
2569	Anhang 1 zum EG-Leitfaden der Guten Herstellungspraxis: Herstellung steriler Arzneimittel
2570	Medical Device Use-Safety:Incorporating Human Factors Engineering into Risk Management
2571	Multisource (generic) pharmaceutical products: guidelines on registration requirements
2572	Propasal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate release, solid oral dosage forms
2573	Additional Guidance for organisators performing in vivo bioequivalence studies
2574	Guidelines for registration of fixed-dose combination medicinal products
2583	COMPLIANCE POLICY GUIDE Sec. 160.900 Prescription Drug Marketing Act - Pedigree Requirements under 21 CFR Part 203
2585	GAMP Good Practice Guide Global Information Systems
2586	GAMP Good Practice Guide IT Infrastructure Control and Compliance
2587	GAMP Good Practice Guide Testing of GxP Systems
2588	GAMP Good Practice Guide Validation of Legacy Systems
2589	GAMP Good Practice Guide A Risk-based Approach to Compliant Electronic Records and Signatures
2590	GAMP Good Practice Guide Validation of Laboratory Computerized Systems
2598	Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices
2599	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
2600	Principles of Medical Devices Classification
2601	Principles of Conformity Assessment for Medical Devices
2602	Information Document Concerning the Definition of the Term “Medical Device”
2603	Medical Devices Post Market Surveillance: Content of Field Safety Notices
2604	Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
2605	Review of Current Requirements on Postmarket Surveillance
2606	Summary of Current Requirements for Where to Send Adverse Event Reports.
2607	Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten
2619	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter
2620	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter
2621	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
2635	M2 eCTD Specification Questions and Answers and Change Requests
2636	M3 Nonclinical Safety Studies for the Conduct of Human Clinical trials for Pharmaceuticals
2637	M4: Granularity Document - Annex to M4: Organization of the CTD
2638	M4: The CTD - General Questions and Answers
2639	M4Q: The CTD - Quality
2640	M4: The CTD - Quality Questions and Answers/Location Issues
2641	M4E: The CTD - Efficacy
2642	M4: The CTD - Efficacy Questions and Answers
2643	M4S: The CTD - Safety
2644	M4S: The CTD - Safety Appendices
2645	M4: The CTD - Safety Questions and Answers
2647	Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide
2648	Labeling OTC Human Drug Products
2659	EC/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
2660	EC/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
2668	Detailed guidance on the European clinical trials database (EUDRACT Database)
2669	Detailed 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
2671	2010/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)
2673	Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use
2674	Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module)
2676	ANNEX 13 - Good Manufacturing Practice for the manufacture of investigational medicinal products
2677	Detailed guidelines on good clinical practice specific to advanced therapy medicinal products
2678	GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS
2679	Chapter 4: Inspections
2681	RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING
2683	Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
2685	DIRECTIVE 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
2686	COMMISSION 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
2687	COMMISSION 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
2709	Liste homöopatischer und antrophosophischer Stoffe
2711	Liste der Schüsslersalze
2712	Liste der dokumentierten traditionellen asiatischen Stoffe
2713	Liste TAS
2722	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Part I (Sept 2009)
2723	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Part II (Sept 2009)
2724	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Annexes (Sept 2009)
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
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
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
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
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: "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
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	ORA Quality Manual
2814	Guidance for Industry Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing
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)"
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
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
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	FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
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	Trinkwasserverordnung
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	COMPLIANCE POLICY GUIDE Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)
2863	Guidance for Industry Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
2864	COMPLIANCE POLICY GUIDES - Foreword
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	PHS Guideline on Infectious Disease Issues in Xenotransplantation
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