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Moving your

biopharmaceutical product

toward regulatory success...

 

 

 

 

 

 

 

 

 

            Useful Links...

 

 

 

 

 

 

 

 

    United States:

        US Food and Drug Administration:  www.fda.gov

        US Code of Federal Regulations (CFRs):  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

        Center for Drugs Evaluation and Research:  www.fda.gov/cder

        Center for Drugs Evaluation and Research, Available Guidance Documents:                                                   

                    www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm

        Center for Biologics Evaluation and Research:  www.fda.gov/cber

        Center for Biologics Evaluation and Research, Available Guidance Documents: 

                    www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm

        Disclosable FDA Warning Letters:  www.fda.gov/foi/warning.htm

        FOI Services, Inc. (provision of FDA documents under Freedom of Information Act, fee):  www.foiservices.com/

 

    Australia:

        Therapeutic Goods Administration:  www.tga.gov.au

 

    Canada:

        Health Canada:  www.hc-sc.gc.ca/dhp-mps/index_e.html

 

    Europe:

        European Medicines Evaluation Agency (EMEA):  http://www.ema.europa.eu      

 

    ICH (International Conference on Harmonization of Technical Requirements for Registration of

    Pharmaceuticals for Human Use):  www.ich.org

 

    Pharmaceutical Industry Groups:

        Biotechnology Industry Organization:  www.bio.org/

        International Federation of Pharmaceutical Manufacturers and Associations (IFPMA):  www.ifpma.org/

        Oregon Bioscience Association:  www.oregonbio.org/

        Oregon Bioscience Incubator/Oregon Translational Research and Development Institute:  www.otradi.org

        Pharmaceutical Research and Manufacturers Association of America (PhRMA):  www.phrma.org

        Washington Biotechnology and Biomedical Association:  www.wabio.com/

       

    Pharmacopoeias:

        US Pharmacopoeia (USP)/National Formulary (NF):  www.usp.org/USPNF

 

    World:

        World Health Organization:  www.who.int/en/