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The FDA expects sponsors of scheduled drugs, particularly drugs in Schedule 2, to include a proposal for post-marketing risk assessment and risk minimization with their NDA submission. Post marketing risk assessment involves some type of surveillance for early signs of a drug abuse epidemic. It involves identifying and characterizing the nature, frequency and severity of the risks throughout a product's life cycle. A risk minimization action plan (RiskMAP) should include a strategic safety program to meet specific goals and objectives in minimizing known or potential risks of a product while preserving its benefits. This might include developing a formulation that minimizes abuse risk, or a plan for targeted education and outreach to communicate risks and appropriate safety behaviors to healthcare practitioners and patients.
Best Practice assists sponsors in preparing the post marketing risk assessment and risk minimization sections of their NDA submission. Following drug approval, Best Practice assists companies in setting up the requisite Expert Advisory Panel to assist the company in analyzing drug surveillance data from publicly available data sets and from specifically targeted efforts; and, Best Practice will assist companies in implementing their risk minimization program. In the abuse liability area, Best Practice is a one-stop specialty service with considerable experience.
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