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Expert Analysis

FDA's Risk Evaluation Guidance Brings Clarity, Not Solutions

By Paul Dietze and Elizabeth Crompton ( April 26, 2019, 4:40 PM EDT) -- This April, the U.S. Food and Drug Administration issued final guidance clarifying how the FDA applies the factors in section 505-1 of the Federal Food, Drug and Cosmetic Act[1] to determine whether a risk evaluation and mitigation strategy is necessary to ensure that the benefits of a drug outweigh its risks....

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