FDA's Risk Evaluation Guidance Brings Clarity, Not Solutions

Law360 (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.

Section 505-1 of the FD&C Act was created as part of the Food and Drug Administration Amendments Act of 2007. A REMS is a required risk management plan to ensure that the benefits of a drug outweigh its risks.

To approve a drug, the FDA must determine that the drug...

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