BLG 699 Study Guide - Final Guide: Gardasil, Polio Vaccine, Plasmodium
22 Jun 2016
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Legislations require drugs to be: developed, tested, trailed, manufactured in accordance to guidelines so that they are safety + patients well-being is protected. Canada = health products + food branch (hpfb) or health. Japan = ministry of health labor welfare (mohlw) w/ Pharmaceutical agencies + medical device agencies (pmda) as regulatory review. Cder center for drug evaluation + research. Oversees the research, development, manufacture, + marketing of synthetic small molecule drugs. Responsible for regulation of certain biologic therapeutic products. Cber regulates certain nontherapeutic biologics which are not regulated by cder. Allergenic allergen extracts (from molds, pollens, insects, insect venoms, and animal hair) for diagnosis and treatment; allergen patch tests; antigen skin tests. Blood and blood products blood and blood components for transfusion or to be manufactured into drug products (e. g. , clotting factors); devices for blood collection, separation, and storage. Cellular and gene therapy products cellular immunotherapies; embryonic and adult stem cells; gene therapy to replace faulty or missing genes.
