Regulations

Code of Federal Regulations (CFR)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
Guidance Documents
http://www.fda.gov/oc/ohrt/irbs/

Government Organizations

Office of Human Research Protection (OHRP)
http://www.hhs.gov/ohrp/
Food and Drug Administration (FDA)
www.fda.gov
National Institute of Health NIH)
www.nih.gov
ClinicalTrials.gov
www.clinicaltrials.gov

FDA Centers and Information for Industry

Center for Drug Evaluation and Research (CDER)
http://www.fda.gov/cder/
Center for Biologics Evaluation and Research (CBER)
http://www.fda.gov/cber/
Center for Devices and Radiological Health (CDRH)
http://www.fda.gov/cdrh/

CDER Approval Process
http://www.fda.gov/cder/info/industry_drug_apprv.htm
CDER Small Business Assistance
http://www.fda.gov/cder/info/industry_drug_apprv.htm

CDRH Approval Process
http://www.fda.gov/cdrh/devadvice/3122.html
CDRH Small Business Assistance
http://www.fda.gov/cdrh/annual/fy2000/ohip/manufact_supp.html

Drug and Device Safety Information

Medwatch – FDA safety information and adverse event Reporting
http://www.fda.gov/medwatch/safety.htm
Public Health Advisories - drug-related warning statements
http://www.fda.gov/cder/news/pubpress.htm
Drug Safety Initiative - variety of information about drug safety issues
http://www.fda.gov/cder/drugSafety.htm
Medical Device Safety – device recalls, alerts, and other information
http://www.fda.gov/cdrh/medicaldevicesafety/

Organizations

Association of Clinical Research Professionals
www.acrpnet.org
Society of Clinical Research Associates
www.socra.org
Regulatory Affairs Professional Society
www.raps.org

Other useful links

CenterWatch – List of Clinical Research Trials
www.centerwatch.com
Medline Plus: Medical Encyclopedia
http://www.nlm.nih.gov/medlineplus/encyclopedia.html
WebMD- Drug Listing
http://www.webmd.com/drugs/
Medical Calculators
http://medicineworld.org/online-medical-calculators.html