Regulatory Affairs -
General Web Resources
Specific topics:
Below are lists of useful web links for course work and professional needs.
If you find a site that you believe would be useful to other regulatory affairs professionals, please email that URL to regaffairs@rx.uga.edu. Let us also know if you find an outdated or broken link so we may replace it. Thank you.
US Government Links
US Government Printing Office: http://www.gpoaccess.gov/
FDA GMP Regulations (CFR21): http://www.access.gpo.gov/nara/cfr/waisidx
_01/21cfr211_01.html
The Code of Federal Regulations (CFR): http://www.gpoaccess.gov/cfr/index.html
US Food and Drug Administration: http://www.fda.gov
The Center for Biologics Evaluation and Research (CBER): http://www.fda.gov/cber/
CBER Guidelines: http://www.fda.gov/cber/guidelines.htm
Office of Regulatory Affairs (ORA): http://www.fda.gov/ora/
Federal Food, Drug, and Cosmetic Act: http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
FDA Modernization Act (FDAMA): http://www.fda.gov/cdrh/modact/modern.html
Good Guidance Practices (GGP): http://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfggp/search.cfm
Product Classification Database: http://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfpcd/search.cfm
Registration Searchable Database: http://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfrl/registra/search.cfm
International Program: http://www.fda.gov/cdrh/international
Investigation Operation Manual: http://www.fda.gov/ora/inspect_ref/iom/iomtc.html
Inspection Reference: http://www.fda.gov/ora/inspect_ref/igs/iglist.html
The Center for Drug Evaluation and Research (CDER): http://www.fda.gov/cder/index.html
cGMP Human Drugs GMP Notes: http://www.fda.gov/cder/index.html
The Center for Devices and Radiological Health (CDRH): http://www.fda.gov/cdrh/index.html
Medical Device Reporting Home Page: http://www.fda.gov/cdrh/mdr/
Listing Searchable Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/Listing/search.cfm
The Center for Food Safety & Applied Nutrition (CFSAN): http://vm.cfsan.fda.gov/list.html
The Center for Veterinary Medicine (CVM): http://www.fda.gov/cvm/default.html
FDA New Releases: http://www.fda.gov/opacom/hpnews.html
US Department of Agriculture: http://www.usda.gov
Laws and Regulations: http://
www.usda.gov/LawsAndRegulations/
Centers for Disease Control: http://www.cdc.gov
Department of Health and Human Services (HHS): http://www.dhhs.gov/
National Institutes of Health (NIH): http://www.nih.gov/
National Cancer Institute (NCI): http://www.nci.nih.gov/
Journal of the National Cancer Institute: http://jncicancerspectrum.oupjournals.org/
The National Library of Medicine: http://www.nlm.nih.gov/
The Visible Human Project: http://www.npac.syr.edu/projects/vishuman/
National Institute of Allergy and Infectious Diseases, National Institutes
of Health http://www.niaid.nih.gov/
National Foundation for Infectious Diseases: http://www.nfid.org/
National Science Foundation (NSF): http://www.nsf.gov/
U.S. Environmental Protection Agency (EPA): http://www.epa.gov/
Biotechnology Program Under Toxic Substances Control Act (TSCA): http://www.epa.gov/opptintr/biotech/index.html
Global Harmonization: http://www.ghtf.org
Regulatory Affairs Resource Links
Regulatory Affairs Information: http://www.rainfo.com/
Regulatory Affairs Professionals Society (RAPS): http://www.raps.org/s_raps/index.asp
AdvaMed (Advanced Medical Technology Association): http://www.advamed.org/
UGA and USG Resource Links
UGA Libraries: http://www.libs.uga.edu/
GALILEO: The University System of Georgia electronic database: http://www.galileo.usg.edu/
Gwinnett University Center Library: http://www.gpc.edu/gusclib/
UGA College of Pharmacy Millikan Educational Resources Center (M.E.R.C.):
http://www.rx.uga.edu/main/home/merc/mercpage/
Through the M.E.R.C website, you can gain access to the following journals
at http://www.rx.uga.edu/main/home/merc/mercpage/pharm_ejournal.html
Science Direct, Elsevier Science, IPA, Annual Review, and AACP Basic
Recourses.
You can also search the College of Pharmacy's holdings at http://www.rx.uga.edu/cgi-bin2/libsearch.exe
The New England Journal of Medicine: http://content.nejm.org/
(Password Protected. You may access this on-line journal using a UGA College
of Pharmacy password. Please contact the Regulatory Affairs Program for
UGA Pharmacy password: regaffairs@rx.uga.edu
or 678-407-5277. You must be registered student to receive this password.)
Life Science & Medical Links
Access Excellence, The National Health Museum: http://www.accessexcellence.org/
Vaccines: http://www.accessexcellence.org/AE/AEC/CC/vaccines_how_why.html
The American Medical Association: http://www.ama-assn.org/
The Journal of the American Medical Association: http://www.ama-assn.org/apps/gk?http://jama.ama-assn.org/
The New England Journal of Medicine: http://content.nejm.org/
(Password Protected. You may access this on-line journal using a UGA College
of Pharmacy password. Please contact the Regulatory Affairs Program for
UGA Pharmacy password: regaffairs@rx.uga.edu
or 678-407-5277. You must be registered student to receive this password.)
Center for Human Simulation: http://www.uchsc.edu/sm/chs/
Development of Polio Vaccines: http://www.accessexcellence.org/AE/AEC/CC/polio.html
DNA Vaccine Information Site: http://dnavaccine.com/
Epidemic! The World of Infectious Disease: http://www.amnh.org/exhibitions/epidemic/
Molecular Expressions: http://micro.magnet.fsu.edu/index.html
The Vaccine Page (from UniScience.net): http://vaccines.org/
The National Library of Medicine: http://www.nlm.nih.gov/
The Visible Human Project: http://www.npac.syr.edu/projects/vishuman/
Scientific Journal Links
BioMed Central: http://www.freemedicaljournals.com/
Blood Cells, Molecules, & Diseases: http://www.scripps.edu/bcmd/
British Medical Journal: http://www.bmj.com
British Pharmacopoeia: http://www.pharmacopoeia.org.uk/
Doctor's Guide Journal Directory: http://www.docguide.com/
Free Medical Journals: http://www.freemedicaljournals.com/
High Wire: http://highwire.stanford.edu/
Journal of Biotechnology: http://www.elsevier.com/
The Journal of Infectious Diseases: http://www.journals.uchicagoss.edu/JID/
Journal of Virology: http://jvi.asm.org/
MedBioWorld (lists of Bioscience Journals): http://www.medbioworld.com/bio/journals/bio-journals.html
Nature Immunology (from Nature Publishing Group): http://www.nature.com/ni/
United States Pharmacopoeia: http://www.usp.org/
International Links
CANADA
Canada Health, Therapeutic Products Directorate: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/
EUROPE (UK links will have separate entry)
European Commission's Pharmacos: http://dg3.eudra.org/home.html
EudraLex: The Rules Governing Medicinal Products in the European Union:
http://pharmacos.eudra.org/F2/eudralex/index.htm
European Guide to GMP: http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm
European Guide to GMP-updates: http://pharmacos.eudra.org/F2/pharmacos/gmp_doc.htm
The European Medicines Agency: http://www.emea.eu.int/
European Guidelines on Quality, Safety & Efficacy: http://www.emea.eu.int/sitemap.htm
Mutual Recognition Agreements: http://www.emea.eu.int/
European Federation of Pharmaceutical Industries & Federations: http://www.efpia.org/
European Pharmacopoeia: Mutual Recognition Agreements Status: http://www.pheur.org/
ASIA (including Australia)
Japanese Ministry of Health, Labour & Welfare: http://www.mhlw.go.jp/english/
Australian Department of Health and Aging: http://www.health.gov.au/
Therapeutic Goods Administration, Australian Regulatory Agency: http://www.health.gov.au/tga/
UNITED KINGDOM
United Kingdom Department of Health: http://www.dh.gov.uk/Home/fs/en
UK Medicines Control Agency: http://www.mca.gov.uk/
WORLD
World Health Organization: http://www.who.int/en/
World Health Organization's Essential Drugs and Medicines Policy: http://www.who.int/medicines/organization/qsm/activities/
qualityassurance/gmp/gmpcover.html
International Pharmaceutical Federation: http://www.fip.org/
International Pharmaceutical Excipients Council: http://www.ipec.org/
Meningitis Vaccine Project: http://www.meningvax.org/
Professional Associations and Societies
Regulatory Affairs Professional Society (RAPS): http://www.raps.org
AdvaMed (Advanced Medical Technology Association): http://www.advamed.org/
Pharmaceutical Research & Manufacturers of America (phRMA): http://www.phrma.org/
Pharmaceutical Inspection Co-operation Scheme (GMP Guide & Basic Standards): http://www.picscheme.org/index.htm
PDA, Parenteral Drug Association, an International Association for Pharmaceutical Science and Technology: http://www.pda.org/
Biotechnology Industry Organization (BIO): http://www.bio.org/
The Food and Drug Law Institute (FDLI): http://www.fdli.org/
National Foundation for Infectious Diseases: http://www.nfid.org/
National Organization for Rare Disorders (NORD): http://www.rarediseases.org/
International Federation of Pharmaceutical Manufacturers Association, (IFPMA): http://www.ifpma.org/
The International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH): http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
ICH Guidelines at the IFPMA site: http://www.ich.org/TxtServer.jser?@_ID=250&@_TEMPLATE=272
The Society for Life Science Professionals: http://www.ispe.org/
Reference Sites
Acronym Finder: http://www.acronymfinder.com/
Dictionary: http://www.dictionary.com
International Organization for Standardization: http://www.iso.ch/iso/en/aboutiso/introduction/index.html
Weights & Measures: http://www.ex.ac.uk/cimt/dictunit/dictunit.htm; http://www.convert-me.com/en/; http://chemistry.berkeley.edu/links/weights/index.html
Return to the top
