| Nr. | Title |
| |
| 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DRAFT GUIDANCE |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DRAFT GUIDANCE |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| 2835 | Draft Guidance for Industry,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DRAFT GUIDANCE |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| 2837 | Draft Guidance for Industry and FDA Staff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| 2838 | Draft Guidance for Industry and FDA Staff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 |
| 2958 | Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Tradtionals Herbal Medicinal Products in the SPC |
| 2966 | Eudralex Volume 8 - Maximum residue limits - Veterinary Medicinal Products |
| 2970 | Q10 PHARMACEUTICAL QUALITY
SYSTEM |
| 3081 | Volume 9a - Pharmacovigilance for Medicinal Products for Human Use |
| 3082 | Volume 9b - Pharmacovigilance for Medicinal Products for VeterinaryUse |
| 3085 | Module 1.2 Application form |
| 3086 | Module 1.2 Homeopathic application form |
| 3087 | User guide for the application form |
| 3095 | Guidance on paper submission with eCTD version 1.0 (February 2006) |
| 3097 | Change Control Process for European eCTD Standards - v1.1 (December 2006) |
| 3099 | Guideline on the processing of renewals in the mutual recognition procedure (October 2005) |
| 3100 | Guideline on the “2nd step”, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s). |
| 3101 | Annex |
| 3116 | GUIDELINE ON ALLERGEN PRODUCTS: PRODUCTION AND QUALITY ISSUES |
| 3117 | GUIDELINE ON PRODUCTION AND QUALITY OF MONOCLONAL ANTIBODIES AND RELATED SUBSTANCES |
| 3118 | GUIDELINE ON POTENCY TESTING OF CELL BASED IMMUNOTHERAPY
MEDICINAL PRODUCTS FOR THE TREATMENT OF CANCER |
| 3119 | GUIDELINE ON THE QUALITY OF BIOLOGICAL ACTIVE SUBSTANCES PRODUCED BY STABLE TRANSGENE EXPRESSION IN HIGHER PLANTS |
| 3120 | GUIDELINE ON DEVELOPMENT AND MANUFACTURE OF
LENTIVIRAL VECTORS |
| 3121 | NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE |
| 3122 | POINTS TO CONSIDER ON THE MANUFACTURE AND QUALITY CONTROL OF HUMAN SOMATIC CELL THERAPY MEDICINAL PRODUCTS |
| 3123 | NOTE FOR GUIDANCE ON THE QUALITY, PRECLINICAL AND CLINICAL ASPECTS OF GENE TRANSFER MEDICINAL PRODUCTS |
| 3124 | NOTE FOR GUIDANCE ON
QUALITY OF BIOTECHNOLOGICAL PRODUCTS: DERIVATION AND
CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF
BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS |
| 3125 | CPMP POSITION STATEMENT ON DNA AND HOST CELL PROTEINS (HCP) IMPURITIES, ROUTINE TESTING VERSUS VALIDATION STUDIES |
| 3126 | NOTE FOR GUIDANCE AN ALLERGEN PRODUCTS |
| 3127 | NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLO-GICAL PRODUCTS:
ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELL LINES USED FOR
PRODUCTION OF
r-DNA DERIVED PROTEIN PRODUCTS |
| 3128 | PRODUCTION AND QUALITY CONTROL OF
MEDICINAL PRODUCTS DERIVED BY
RECOMBINANT DNA TECHNOLOGY |
| 3129 | PRODUCTION AND QUALITY CONTROL OF
MONOCLONAL ANTIBODIES |
| 3130 | GENE THERAPY PRODUCT QUALITY ASPECTS
IN THE PRODUCTION OF VECTORS AND
GENETICALLY MODIFIED SOMATIC CELLS |
| 3131 | USE OF TRANSGENIC ANIMALS IN THE
MANUFACTURE OF BIOLOGICAL MEDICINAL
PRODUCTS FOR HUMAN USE |
| 3132 | PRODUCTION AND QUALITY CONTROL OF
CYTOKINE PRODUCTS DERIVED BY
BIOTECHNOLOGICAL PROCESSES |
| 3133 | NOTE FOR GUIDANCE ON
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR
BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS |
| 3134 | TESTS ON SAMPLES OF BIOLOGICAL ORIGIN |
| 3135 | GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING
BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES |
| 3136 | GUIDELINE ON
SIMILAR BIOLOGICAL MEDICINAL PRODUCTS |
| 3137 | NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS |
| 3138 | GUIDELINE ON COMPARABILITY OF MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROETINS AS ACTIVE SUBSTANCE: QUALITY ISSUES |
| 3139 | NOTE FOR GUIDANCE ON PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3140 | GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER
FILE (PMF) Revision 1 |
| 3141 | ANNEXES TO
GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1 |
| 3142 | GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF
ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (ANTI-HIV) IN PLASMA POOLS |
| 3143 | GUIDELINE ON VALIDATION OF IMMUNOASSAY FOR THE DETECTION OF
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) IN PLASMA POOLS |
| 3144 | GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD
TRANSMISSIBLE INFECTIONS
For inclusion in the Guideline on the Scientific data requirements for a Plasma Master File |
| 3145 | GUIDELINE ON THE REQUIREMENTS FOR PLASMA MASTER FILE (PMF) CERTIFICATION |
| 3146 | GUIDELINE ON ASSESSING THE RISK FOR VIRUS TRANSMISSION
– NEW CHAPTER 6 OF THE NOTE FOR GUIDANCE ON PLASMADERIVED
MEDICINAL PRODUCTS |
| 3147 | GUIDELINE ON THE INVESTIGATION OF MANUFACTURING
PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS
WITH REGARD TO VCJD RISK |
| 3148 | CHMP POSITION STATEMENT ON CREUTZFELDT-JACOB DISEASE and PLASMA-DERIVED AND URINE-DERIVED MEDICINAL PRODUCTS |
| 3149 | CPMP POSITION STATEMENT ON WEST NILE VIRUS AND PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3150 | CPMP POSITION STATEMENT NON-REMUNERATED AND REMUNERATED DONORS: SAFETY AND SUPPLY OF PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3151 | PLASMA-DERIVED MEDICINAL PRODUCTS: POSITION PAPER ON
ALT TESTING |
| 3152 | GUIDELINE ON DOSSIER STRUCTURE AND CONTENT OF MARKETING
AUTHORISATION APPLICATIONS FOR INFLUENZA VACCINES DERIVED FROM
STRAINS WITH A PANDEMIC POTENTIAL FOR USE OUTSIDE OF THE CORE
DOSSIER CONTEXT |
| 3153 | GUIDELINE ON ADJUVANTS IN VACCINES FOR HUMAN USE |
| 3154 | EXPLANATORY NOTE ON IMMUNOMODULATORS FOR THE GUIDELINE ON
ADJUVANTS IN VACCINES FOR HUMAN USE |
| 3155 | GUIDELINE ON DOSSIER STRUCTURE AND CONTENT FOR PANDEMIC INFLUENZA VACCINE MARKETING AUTHORISATION APPLICATION |
| 3156 | GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE |
| 3157 | GUIDELINE ON REQUIREMENTS FOR VACCINE ANTIGEN MASTER
FILE (VAMF) CERTIFICATION |
| 3158 | CPMP POSITION STATEMENT ON THE QUALITY OF WATER USED IN THE PRODUCTION OF VACCINES FOR PARENTERAL USE |
| 3159 | GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A
VACCINE ANTIGEN MASTER FILE (VAMF) |
| 3160 | CELL CULTURE INACTIVATED INFLUENZA VACCINES ANNEX TO NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES (CPMP/BWP/214/96) |
| 3161 | POINTS TO CONSIDER ON THE DEVELOPMENT OF LIVE ATTENUATED INFLUENZA VACCINES |
| 3162 | NOTE FOR GUIDANCE ON THE DEVELOPMENT OF VACCINA VIRUS BASED VACCINES AGAINST SMALLPOX |
| 3163 | POINTS TO CONSIDER ON THE REDUCTION, ELIMINATION OR SUBSTITUTION OF THIOMERSAL IN VACCINES |
| 3164 | Public Statement on the Evaluation of Bovine Spongiform Encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines |
| 3165 | NOTE FOR GUIDANCE ON PHARMACEUTICAL AND BIOLOGICAL ASPECTS OF COMBINED VACCINES |
| 3166 | NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES |
| 3167 | QUALITY OF BIOTECHNOLOGICAL PRODUCTS:
STABILITY TESTING OF BIOTECHNOLOGICAL/
BIOLOGICAL PRODUCTS |
| 3168 | Guidance on a new therapeutic indication for a well established substance (November 2007) |
| 3169 | DEVELOPMENT PHARMACEUTICS FOR BIOTECHNOLOGICAL AND BIOLOGICAL PRODUCTS (CPMP/BWP/328/99) ANNEX TO NOTE FOR GUIDANCE ON DEVELOPMENT PHARMACEUTICS (CPMP/QWP/155/96) |
| 3170 | GUIDELINE ON POTENCY LABELLING FOR INSULIN ANALOGUE CONTAINING PRODUCTS WITH PARTICULAR REFERENCE TO THE USE OF “INTERNATIONAL UNITS” OR “UNITS” |
| 3171 | Guidance on elements required to support the significant benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period (November 2007) |
| 3172 | CORE SPC FOR PANDEMIC INFLUENZA VACCINES |
| 3173 | GUIDELINE ON PHARMACEUTICAL ASPECTS OF THE PRODUCT INFORMATION FOR HUMAN VACCINES |
| 3174 | NOTE FOR GUIDANCE ON THE WARNING ON TRANSMISSIBLE AGENTS IN SUMMARY OF PRODUCT CHARACTERISTICS (SPCs) AND PACKAGE LEAFLETS FOR PLASMA-DERIVED MEDICINAL PRODUCTS |
| 3175 | GUIDANCE ON THE DESCRIPTION OF COMPOSITION OF PEGYLATED (CONJGATED) PROTEINS IN THE SPC |
| 3176 | GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS |
| 3177 | NOTE FOR GUIDANCE ON THE USE OF BOVINE SERUM IN THE MANUFACTURE OF HUMAN BIOLOGICAL MEDICINAL PRODUCTS |
| 3178 | POSITION PAPER ON VIRAL SAFETY OF ORAL POLIOVIRUS VACCINE (OPV) |
| 3179 | NOTE FOR GUIDANCE ON
QUALITY OF BIOTECHNOLOGICAL PRODUCTS: VIRAL SAFETY
EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVE |
