SDRAN
RESOURCESRegulatory Affairs Resources: Professional Organizations and Education Opportunities
UCI Division of Continuing Education
Offers fully online certificate programs in the following areas: Clinical Trials, Healthcare Analytics, Medical Product Development and Regulatory Affairs. Discount code provided for SDRAN members to get 10% off of any Life Sciences courses provided. Discount...
Regulatory Resources USA: FDA and Related Resources
CMS Center for Medicare and Medicaid Service
For HHS programs, reimbursement, and other information VISIT SITE
FDA (Food and Drug Administration)
Regulatory Resources USA: FDA and Related Resources The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and...
HIPAA (HHS)
The USA Health and Human Services website for information on National Standards to Protect the Privacy of Personal Health Information (e.g., for clinical trials information) VISIT SITE
Outside United States (OUS) Regulatory Resources: Other National Regulatory Agencies and International Regulatory Resources
Health Canada
Health Canada's Therapeutic Products Directorate is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a...
Pharma and Biotech Industry Associations
ASCP American Society for Clinical Pathology
A not-for-profit medical society organized exclusively for educational, scientific, and charitable purposes. The mission of the American Society for Clinical Pathology is to provide excellence in education, certification, and advocacy on behalf of patients,...
National Association of Boards of Pharmacy
A professional organization representing the state boards of pharmacy VISIT SITE
Society of Toxicology
A professional and scholarly organization of scientists from academic institutions, government, and industry representing the great variety of professionals who practice toxicology in the U.S. and abroad. Has a good page of URL links VISIT SITE
Device Industry Organizations & Other Resources
AMDM Association of Medical Diagnostics Manufacturers
A nonprofit trade association that serves as a resource for education and information on compliance issues between member companies and as an interface between member companies (IVDs) and the FDA VISIT SITE