Life Science Resources

 Resources

Food and Drug Administration
Center for Drug Evaluation and Research
Code of Federal Regulations Title 21
FDA Forms and Distribution Page for CDER
FDA Information Sheets
FDA Office of Regulatory Affairs
Food, Drug and Cosmetic Act
Guidance Documents Web Page
New and Generic Drug Approvals
USA Food and Drug Administration Home Page

 

Health Organizations and Associations
American Association of Cardiovascular and Pulmonary Rehabilitation
American Medical Association (AMA)
Association of Clinical Research Professionals (ACRP)
CardioSource
International Academy of Cardiology
International Conference on Harmonisation (ICH)
National Institute of Health (NIH)
World Health Organization (WHO)

 

International Regulatory Affairs
European Agency for the Evaluation of Medicinal Products (EMEA)
Health Products and Food Branch - Canada
Ministry of Health, Labour and Welfare - Japan
Mutual Recognition; Heads of Agencies

 

Periodicals
Genetic Engineering News

 

Whitepapers
Ten Most Common Reasons for 483
Increasing Clinical Trial Efficiencies with Activity-based Costing

 

Additional Associations and Resources
Association of Clinical Research Professionals (ACRP)
CenterWatch
Drug Information Association (DIA)
RegSource
Regulatory Affairs Professional Society (RAPS)
Society of Clinical Research Associates (SoCRA)
USA Freedom of Information Services, Inc. (FOIS)