| Nr. | Title |
| |
| 2252 | Guide to good storage practices for pharmaceuticals |
| 2253 | Quality assurance of pharmaceuticals: a compendium of guidelines and related materials |
| 2254 | Quality system requirements for national GMP inspectorates |
| 2255 | Pre-approval inspections |
| 2256 | Inspection of pharmaceutical manufacturers |
| 2257 | Inspection of drug distribution channels |
| 2258 | Guidance on GMP: Inspection Report |
| 2259 | Model Certificate of GMP |
| 2260 | Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms |
| 2261 | The International Pharmacopoeia |
| 2262 | Index of national, regional and international pharmacopoeias |
| 2263 | Lists of available International Chemical Reference Substances and International Infrared Reference Spectra |
| 2264 | Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products |
| 2265 | The International Pharmacopoeia: revised concepts and future perspectives |
| 2266 | Orally Disintegrating Tablets |
| 2267 | Considerations for requesting analyses of drug samples |
| 2268 | Model certificate of analysis |
| 2269 | Good practices for national pharmaceutical control laboratories |
| 2270 | Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies |
| 2271 | Guidelines for preparing a laboratory information file |
| 2272 | Quality control methods for medicinal plant materials |
| 2273 | Update, Item 11.1 TRS 908 |
| 2274 | Consultation of Stability studies in a global environment |
| 2275 | Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products |
| 2276 | Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms |
| 2277 | Guidelines on packaging for pharmaceutical products |
| 2278 | Guidelines on import procedures for pharmaceutical products |
| 2282 | DIN EN ISO 17025 (Ausgabe 2005-08) Allgemeine Anforderungen an die Kompetenz von Prüf- und Kalibrierlaboratorien |
| 2283 | Implementatin of risk management principles and activities within a QMS |
| 2284 | Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products |
| 2285 | Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices |
| 2286 | Quality System Information
for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff |
| 2287 | Medical Device Use-Safety:
Incorporating Human Factors
Engineering into Risk Management |
| 2289 | HUMAN FACTORS PRINCIPLES
FOR MEDICAL DEVICE LABELING (A) |
| 2290 | HUMAN FACTORS PRINCIPLES
FOR MEDICAL DEVICE LABELING(B) |
| 2291 | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| 2298 | Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007 |
| 2299 | Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-2) Sept 2007 |
| 2300 | Aide Memoire on Inspection of Quality Control Laboratories(PI 023-2) Sept 2007 |
| 2301 | Updated 510(k) Sterility Review Guidance K90-1;
Final Guidance for Industry and FDA |
| 2302 | Premarket Notifications [510(k)]for Biological Indicators
Intended to Monitor Sterilizers Used in Health Care Facilities;
Draft Guidance for Industry and FDA Reviewers |
| 2303 | CDRH Manual for the
Good Guidance Practices
(GGP) Regulations; Final
Guidance for FDA Staff |
| 2306 | Guidance On Quality Systems For The Design
And Manufacture Of Medical Devices |
| 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 I Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC) |
| 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) |
| 2348 | Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC |
| 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 |
| 2370 | Annual Reports for Approved Premarket Approval Applications (PMA) |
| 2507 | MEDICINAL PRODUCTS ACT (THE DRUG LAW) - (ARZNEIMITTELGESETZ – AMG)of the FEDERAL REPUBLIC OF GERMANY |
| 2534 | AIDE-MEMOIRE ON THE INSPECTION OF MEDICINAL GASES PI 025-2 |
| 2547 | Guidance on Parametric Release (PIC/S PI 005-3) |
| 2560 | Guide to Good Manufacturing Practices of preparation of medicinal products in pharmacies (PIC/S PE 010-2) |
| 2565 | Water for pharmaceutical use |
| 2566 | Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms |
| 2567 | WHO Supplementary Guideline on Good Manufacturing Practices: Validation |
| 2568 | Good distribution practice for pharmaceutical products |
| 2570 | Update, Item 10.1. TRS 937, 2006 |
| 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 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. |
| 2608 | GENERAL REQUIREMENTS FOR THE PRODUCTION AND CONTROL OF LIVE MAMMALIAN BACTERIAL AND VIRAL VACCINES FOR VETERINARY USE |
| 2609 | GENERAL REQUIREMENTS FOR THE PRODUCTION
AND CONTROL OF INACTIVATED MAMMALIAN BACTERIAL AND VIRAL VACCINES FOR VETERINARY USE |
| 2610 | SPECIFIC REQUIREMENTS FOR THE PRODUCTION
AND CONTROL OF AVIAN LIVE AND INACTIVATED
VIRAL AND BACTERIAL VACCINES |
| 2612 | SPECIFIC REQUIREMENTS FOR THE PRODUCTION
AND CONTROL OF PIG LIVE AND INACTIVATED
VIRAL AND BACTERIAL VACCINES |
| 2613 | SPECIFIC REQUIREMENTS FOR THE PRODUCTION
AND CONTROL OF OVINE AND CAPRINE LIVE AND
INACTIVATED VIRAL AND BACTERIAL VACCINES |
| 2614 | SPECIFIC REQUIREMENTS FOR THE PRODUCTION
AND CONTROL OF EQUINE LIVE AND INACTIVATED
VIRAL AND BACTERIAL VACCINES |
| 2615 | MANUFACTURE OF THE FINISHED DOSAGE FORM |
| 2616 | LIST OF QUALITY GUIDELINES ACCEPTED FROM
THE GUIDELINES FOR HUMAN USE |
| 2618 | Current Good Manufacturing Practice;
Amendment of Certain Requirements
For Finished Pharmaceuticals Withdrawal |
| 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 |
| 2621 | The Use of Mechanical Calibration
of Dissolution Apparatus 1 and 2 –
Current Good Manufacturing Practice
(CGMP) |
| 2635 | M2 eCTD Specification Questions and Answers adn Change Requests |
| 2636 | M3 Nonclinical Safety Studies for the Conduct of Human Clinical trials for Phramaceuticals |
| 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 |
| 2667 | Table of Contents - Foreword - General Information |
| 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 | Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial |
| 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 - Manufacture of investigational medicinal products |
| 2677 | COMPILATION OF COMMUNITY PROCEDURES ON INSPECTIONS AND EXCHANGE OF INFORMATION: COMMUNITY BASIC FORMAT FOR MANUFACTURER’S
AUTHORISATION |
| 2678 | GUIDELINE ON THE REQUIREMENTS TO THE CHEMICAL AND PHARMACEUTICAL QUALITY DOCUMENTATION CONCERNING INVESTIGATIONAL MEDICINAL PRODUCTS IN CLINICAL TRIALS |
| 2679 | Chapter 4: Recommendation on Inspections |
| 2681 | RECOMMENDATION ON THE CONTENT OF THE TRIAL
MASTER FILE AND ARCHIVING |
| 2682 | VOLUME 10 - NOTICE TO APPLICANTS: Questions & Answers - Clinical Trial Documents |
| 2683 | Good Clinical Practice |
| 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 |
| 2710 | DIRECTIVE 2008/29/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission |
| 2714 | The joint IPEC-PQG Good Manufacturing Practices guide for Pharmaceutical Excipients |
| 2715 | IPEC Good Distribution Practices Guide for Pharmaceutical Excipients |
| 2716 | IPEC Good Manufacturing Practices Audit Guideline for Bulk Pharmaceutical Excipients |
| 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 |
| 2763 | Food and Drug Administration Modernization Act of 1997; Allergenic Patch Test Kits; Request for Comments or Data |
| 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) |
