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 Let us also know if you find an outdated or broken link so we may replace it.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: www.gpoaccess.gov/
FDA GMP Regulations (CFR21): www.access.gpo.gov/nara/cfr/waisidx
_01/21cfr211_01.html
The Code of Federal Regulations (CFR): www.gpoaccess.gov/cfr/index.html
US Food and Drug Administration:
www.fda.gov
The Center for Biologics Evaluation and Research (CBER): www.fda.gov/cber
CBER Guidelines: www.fda.gov/cber/guidelines.htm
Office of Regulatory Affairs (ORA): www.fda.gov/ora/
Federal Food, Drug, and Cosmetic Act: www.fda.gov/opacom/laws/fdcact/fdctoc.htm
FDA Modernization Act (FDAMA): www.fda.gov/cdrh/modact/modern.html
Good Guidance Practices (GGP): www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfm
Product Classification Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/search.cfm
Registration Searchable Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/registra/
search.cfm
International Program: www.fda.gov/cdrh/international
Investigation Operation Manual: www.fda.gov/ora/inspect_ref/iom/iomtc.html
Inspection Reference: www.fda.gov/ora/inspect_ref/igs/iglist.html
The Center for Drug Evaluation and Research (CDER): www.fda.gov/cder/index.html
cGMP Human Drugs GMP Notes: www.fda.gov/cder/index.html
The Center for Devices and Radiological Health (CDRH): www.fda.gov/cdrh/index.html
Medical Device Reporting Home Page: www.fda.gov/cdrh/mdr/
Listing Searchable Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/Listing/search.cfm
The Center for Food Safety & Applied Nutrition (CFSAN): vm.cfsan.fda.gov/list.html
The Center for Veterinary Medicine (CVM): www.fda.gov/cvm/default.html
FDA New Releases: www.fda.gov/opacom/hpnews.html
US Department of Agriculture: www.usda.gov
Laws and Regulations: www.usda.gov/LawsAndRegulations/
Centers for Disease Control: www.cdc.gov
Department of Health and Human Services (HHS): www.dhhs.gov/
National Institutes of Health (NIH): www.nih.gov
National Cancer Institute (NCI): www.nci.nih.gov/
Journal of the National Cancer Institute: jncicancerspectrum.oupjournals.org/
The National Library of Medicine: www.nlm.nih.gov/
The Visible Human Project: www.npac.syr.edu/projects/vishuman/
National Institute of Allergy and Infectious Diseases, National Institutes
of Health www.niaid.nih.gov/
National Foundation for Infectious Diseases: www.nfid.org
National Science Foundation (NSF): www.nsf.gov
U.S. Environmental Protection Agency (EPA): www.epa.gov
Biotechnology Program Under Toxic Substances Control Act (TSCA): www.epa.gov/opptintr/biotech/index.html
Global Harmonization: www.ghtf.org
Regulatory Affairs Resource Links
Regulatory Affairs Information: www.rainfo.com
Regulatory Affairs Professionals Society (RAPS): www.raps.org/s_raps/index.asp
AdvaMed (Advanced Medical Technology Association): www.advamed.org
UGA and USG Resource Links
UGA Libraries: www.libs.uga.edu
GALILEO: The University System of Georgia electronic database: www.galileo.usg.edu/
Gwinnett University Center Library: www.gpc.edu/gusclib/
UGA College of Pharmacy Millikan Educational Resources Center (M.E.R.C.):
www.rx.uga.edu/main/home/merc/mercpage/
Through the M.E.R.C website, you can gain access to the following journals
at 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 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: www.accessexcellence.org/
Vaccines: www.accessexcellence.org/AE/AEC/CC/vaccines_how_why.html
The American Medical Association: www.ama-assn.org
The Journal of the American Medical Association: www.ama-assn.org/apps/gk?
The New England Journal of Medicine: content.nejm.org/
(Password Protected. You may access this online journal using a UGA College
of Pharmacy password. Please contact the Regulatory Affairs Program for
UGA Pharmacy password: regaffairs@rx.uga.edu. You must be registered student to receive this password.)
Center for Human Simulation: www.uchsc.edu/sm/chs/
Development of Polio Vaccines: www.accessexcellence.org/AE/AEC/CC/polio.html
DNA Vaccine Information Site: dnavaccine.com/
Epidemic! The World of Infectious Disease: www.amnh.org/exhibitions/epidemic/
Molecular Expressions: micro.magnet.fsu.edu/index.html
The Vaccine Page (from UniScience.net): vaccines.org/
The National Library of Medicine: www.nlm.nih.gov/
The Visible Human Project: www.npac.syr.edu/projects/vishuman/
Scientific Journal Links
BioMed Central: www.freemedicaljournals.com/
Blood Cells, Molecules, & Diseases: www.scripps.edu/bcmd/
British Medical Journal: www.bmj.com
British Pharmacopoeia: www.pharmacopoeia.org.uk/
Doctor's Guide Journal Directory: www.docguide.com/
Free Medical Journals: www.freemedicaljournals.com/
High Wire: http://highwire.stanford.edu/
Journal of Biotechnology: www.elsevier.com/
The Journal of Infectious Diseases: www.journals.uchicagoss.edu/JID/
Journal of Virology: http://jvi.asm.org/
MedBioWorld (lists of Bioscience Journals): www.medbioworld.com/bio/journals/bio-journals.html
Nature Immunology (from Nature Publishing Group): www.nature.com/ni/
United States Pharmacopoeia: www.usp.org
International Links
CANADA
Canada Health, Therapeutic Products Directorate: 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:
pharmacos.eudra.org/F2/eudralex/index.htm
European Guide to GMP: pharmacos.eudra.org/F2/eudralex/vol-4/home.htm
European Guide to GMP-updates: pharmacos.eudra.org/F2/pharmacos/gmp_doc.htm
The European Medicines Agency: www.emea.eu.int/
European Guidelines on Quality, Safety & Efficacy: www.emea.eu.int/sitemap.htm
Mutual Recognition Agreements: www.emea.eu.int/
European Federation of Pharmaceutical Industries & Federations: www.efpia.org/
European Pharmacopoeia: Mutual Recognition Agreements Status: www.pheur.org/
ASIA (including Australia)
Japanese Ministry of Health, Labour & Welfare: www.mhlw.go.jp/english/
Australian Department of Health and Aging: www.health.gov.au/
Therapeutic Goods Administration, Australian Regulatory Agency: www.health.gov.au/tga/
UNITED KINGDOM
United Kingdom Department of Health: www.dh.gov.uk/Home/fs/en
UK Medicines Control Agency: www.mca.gov.uk
WORLD
World Health Organization: www.who.int/en/
World Health Organization's Essential Drugs and Medicines Policy: www.who.int/medicines/organization/qsm/activities/
qualityassurance/gmp/gmpcover.html
International Pharmaceutical Federation: www.fip.org
International Pharmaceutical Excipients Council: www.ipec.org
Meningitis Vaccine Project: www.meningvax.org
Professional Associations and Societies
Regulatory Affairs Professional Society (RAPS): www.raps.org
AdvaMed (Advanced Medical Technology Association): www.advamed.org
Pharmaceutical Research & Manufacturers of America (phRMA): www.phrma.org
Pharmaceutical Inspection Co-operation Scheme (GMP Guide & Basic Standards): www.picscheme.org/index.htm
PDA, Parenteral Drug Association, an International Association for Pharmaceutical Science and Technology: www.pda.org
Biotechnology Industry Organization (BIO): www.bio.org
The Food and Drug Law Institute (FDLI): www.fdli.org
National Foundation for Infectious Diseases: www.nfid.org
National Organization for Rare Disorders (NORD): www.rarediseases.org
International Federation of Pharmaceutical Manufacturers Association, (IFPMA): www.ifpma.org
The International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH): www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
ICH Guidelines at the IFPMA site: www.ich.org/TxtServer.jser?@_ID=250&@_TEMPLATE=272
The Society for Life Science Professionals: www.ispe.org
The Emerging Leaders Network: www.gabio.org/content.aspx?pageid=12
The Emerging Leaders Network (ELN), a division of Georgia Bio (GaBio), is devoted to promoting networking between emerging and established professionals within the Georgia Life Sciences Community. ELN’s programs are designed to facilitate the growth and development of Georgia-based biotechnology academic institutions, industries and service providers.
Reference Sites
Acronym Finder: www.acronymfinder.com
Dictionary: www.dictionary.com
International Organization for Standardization: www.iso.ch/iso/en/aboutiso/introduction/index.html
Weights & Measures: www.ex.ac.uk/cimt/dictunit/dictunit.htm; www.convert-me.com/en/; chemistry.berkeley.edu/links/weights/index.html
