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SEQUENTIAL PROCESS
• Process of discovering, developing and bringing to the market, a new ethical drug product
• Drug must be proved to be safe and effective
NEW DRUG APPLICATION REVIEW
• NDA: Positive previous testing • Information from DRUG DEVELOPMENT to phase III
(CLINICAL PHASE).– Animal and human data and analyses of the data.– New drug behaves in the body.– New drug manufactured.
• Post – marketing studies.– SAFETY and EFFICACY during long term use.– Submit periodic safety data