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As part of the Food and Drug Administration’s (“FDA”) ongoing and comprehensive efforts to minimize risks while preserving the benefits of medical products, the FDA recently released three industry guidance documents on risk management strategies. These final guidance documents, applicable to various stages of drug and biological product development, will assist manufacturers in developing and improving methods to assess and monitor the risks associated with drugs and biologics. The risk minimization action plan is one of these initiatives that promises to further tip the balance of the risk-benefit profile of drugs and devices.

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