:: BioReliance ::


		Introduction FDA EMEA ICH

Donna Klein joins Bioreliance Donna Klein has been named Vice President, Human Resources, responsible for the human resource functions for all the company's locations including the United States, United Kingdom and Asia.
Click here to read the press release.

Darryl L. Goss joins Bioreliance Darryl L. Goss has been appointed Vice President, Toxicology/Laboratory Animal Diagnostic Services (LADS), a new executive position created to lead this newly formed Business Unit.
Click here to read the press release.

This page provides access to regulatory guidance and other resources that are generally available from web sites operated and maintained by other organisation.

U.S. Food and Drug Administration (FDA): Centre for Biologics Evaluation and Research

Documents that are available from CBER include: approvals and product information, blood memoranda, error/accident reports, Federal Register notices, general/administrative information, guidelines/guidances, letters to manufacturers, points to consider, and recall/withdrawal/safety issues.

New regulatory guidance and other resources for toxicology are now available.

DOCUMENT TITLE* *Note: these links take you directly to the documents on the FDA web site. Please let us (info@bioreliance.com) know if you have problems accessing them.	DOCUMENT TYPE	DATE POSTED on this website
Draft Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection	Draft Guidance	June 2005
Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications	Draft Guidance	June 2005
ICH Draft Guidance on Q8 Pharmaceutical Development Further information	Draft Guidance	June 2005
Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Further information	Draft Guidance	February 2005
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)	Guidance for Industry	February 2005
Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors 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	Guidance for Industry	February 2005
Current Good Manufacturing Practice for Combination Products Further information	Draft Guidance for Industry	February 2005
Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice Further information	Guidance for Industry	February 2005
Screening and Testing of Donors of Human Tissue Intended for Transplantation - Current Guidance (1997)	Current Guidance	September 2004
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)	Draft Guidance	September 2004
Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments Part 2: Clinical Indications Part 3: Design, Analysis, and Interpretation of Clinical Studies	Guidance for Industry	June 2004
Q1E Evaluation of Stability Data	Guidance for Industry	June 2004
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Further information	Draft Guidance	May 2004
ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process	Draft Guidance	March 2004
Draft Guidance on CMC of IND for Human Somatic Cell Therapies Further information	Draft Guidance for Industry	NEW August 2003
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans Further information	Guidance for Industry	UPDATED August 2003
Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals Further information	Draft Guidance for Industry	September 2002
Draft Guidance for Industry regarding Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Further information	Draft Guidance for Industry	August 2002
Gene Therapy Patient Tracking System Further information	FDA System Document	August 2002
Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts Further information	Guidance for Industry	February 2002
Revised precautionary measures to reduce the possible risk of CJD and new variant CJD by blood and blood products* Further information	Guidance for Industry	January 2002
Guidance on M4 Common Technical Document: Organization of the Common Technical Document Further information	Guidance for Industry	2001
Guidance on M4 Common Technical Document: The CTD - Quality	Guidance for Industry	2001
Guidance on M4 Common Technical Document: The CTD - Efficacy	Guidance for Industry	2001
Guidance on M4 Common Technical Document: The CTD - Safety	Guidance for Industry	2001
Guidance on M4 Common Technical Document: The CTD - Safety Appendices	Guidance for Industry	2001
Guidance for monoclonal antibodies used as reagents in drug manufacturing*	Guidance for Industry	2001
Letter to sponsors on use of Vero cells for investigational vaccines *	Letter	2001
Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans*	Draft Guidance	2001
Guidelines on Infectious Disease Issues in Xenotransplantation*	PHS Guidelines	2001
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. *	Guidance for Industry	2000
Letter to sponsors of INDs or master files; guidance for manufacturers of gene therapy products*.	Letter	2000
Cooperative Manufacturing Arrangements for Licensed Biologics*	Draft Guidance for Industry	1999
Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans*	Guidance for Industry	1999
Guidance for Human Somatic Cell Therapy and Gene Therapy*	Guidance for Industry	1998
Letter to Viral Vaccine IND Sponsors - Use of PCR-based Reverse Transcription Assay*	Letter	1998
Guide to Inspections of Viral Clearance Processes for Plasma Derivatives*	FDA Office of Regulatory Affairs Inspectional References	1998
Manufacture and Testing of Monoclonal Antibody Products for Human Use*	Points to Consider	1997
Guidance in Applications for Products Comprised of Living Autologous Cells Manipulated Ex vivo and Intended for Structural Repair or Reconstruction*	Guidance for Industry	1996
Plasmid DNA vaccines for Preventative Infectious Disease Indications*	Points to Consider	1995
Manufacture and Testing of therapeutic Products for Human Use Derived from Transgenic Animals*	Points to Consider	1995
Characterisation of Cell Lines Used to Produce Biologicals*	Points to Consider	1993
Production and testing of New Drugs and Biologicals Produced by Recombinant DNA Technology	Points to Consider	1985
TOXICOLOGY
S8 Immunotoxicity Studies for Human Pharmaceuticals – Step 2 Released for consultation Further information	Draft Guidance	February 2005
Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies Further information	US policy document	February 2005
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals	Guidance for Industry	February 2005
Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals	Guidance for Industry	February 2005

IMPORTANT NOTICE
The links on this page are provided for the sole purpose of assisting visitors to locate the relevant web sites and BioReliance does not make any warranty with respect to the accuracy of the documents available from these sites. All documents are the copyright of the respective site owners and may be subject to certain conditions of use. Although care has been taken in the preparation of this web site BioReliance cannot be held responsible for the accuracy of the information contained within the web site, nor for any consequence arising from such information. You are advised to seek additional advice when making decisions based on information you have obtained from this web site.

for further information and enquiries please contact: info@bioreliance.com