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Home » PREMARKETING STUDY IS FIRST STEP IN RISK MANAGEMENT PLAN
PREMARKETING STUDY IS FIRST STEP IN RISK MANAGEMENT PLAN
May 19, 2004
When assessing the risks of an investigational drug, drugmakers may need to build larger safety databases, especially in connection with proposed treatments for which a safe and effective alternative is already in use, according to an FDA draft guidance on risk management released earlier this month.