BioFinity Consulting, LLC
Moving your biopharmaceutical product toward the finish line...
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/cder/guidance/index.htm
Center for Biologics Evaluation and Research: www.fda.gov/cber
Center for Biologics Evaluation and Research, Available Guidance Documents: www.fda.gov/cber/reading.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: http://www.hc-sc.gc.ca/dhp-mps/index_e.html
Europe:
European Medicines Evaluation Agency (EMEA): www.emea.eu.int/
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/
Pharmaceutical Research and Manufacturers Association of America (PhRMA): www.phrma.org
Oregon Bioscience Association: www.oregonbio.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/
