Food and Drug Administration
cGMP: Federal regulations on manufacture of pharmaceuticals (21CFR210-211)
Federal regulations applying to biologics (21CFR600-680)
cGTP: Federal regulations applying to human cell and tissue products (21CFR1271)
FDA Center for Biologics Evaluation and Research (CBER) home page. CBER oversees blood and blood products, vaccines, and gene therapies
Guidance documents from CBER
FDA Center for Drug Evaluation and Research (CDER) home page. CDER oversees traditional small molecule drugs and monoclonal antibody therapies
Guidance documents from CDER
European Medicine Agency
Health Canada
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