Useful Links
USA
-
Food and Drug Administration (FDA) Home Page
http://www.fda.gov/ -
FDA - Center for Biologics Evaluation and Research
http://www.fda.gov/cber -
FDA - Center for Drug Evaluation and Research
http://www.fda.gov/cder -
FDA - Codes of Federal Regulations
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm -
FDA- Inspectional References and Guides
http://www.fda.gov/ora/inspect_ref/default.htm -
FDA - CDER Guidance Documents Index
http://www.fda.gov/cder/guidance/index.htm -
FDA - CBER Guidance Documents Index
http://www.fda.gov/cber/reading.htm -
FDA - Warning Letters
http://www.fda.gov/foi/warning.htm
Europe
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European Medicines Evaluation Agency
http://www.emea.eu.int/ -
"Eudralex" Rules Governing Medicinal Products in the EU
http://pharmacos.eudra.org/F2/eudralex/index.htm -
Eudralex Volume 4 (GMP) and its Annexes
http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm
ICH, International Conference on Harmonization
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International Conference on Harmonization Home Page
http://www.ich.org
Canada
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Health Canada
http://www.hc-sc.gc.ca
Australia
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Therapeutic Goods Administration
http://www.tga.gov.au
Pharmaceutical Inspection Co-operation Scheme
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Pharmaceutical Inspection Co-operation Scheme: PIC/S
http://www.picscheme.org/index.htm
WHO, World Health Organization
Pharmacopoeias
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US Pharmacopoeia
http://www.usp.org
Don Hill & Associates, Inc
Main Office (301) 260-2200 Fax (301) 260-2020
eMail: dhai@msn.com
