Describe some of the ways in which the benefit

Reference no: EM133435677

Question: The concept of benefit: risk in the context of drug/biologic/device safety is a primary feature of the regulation and guidance relevant to safety and Pharmacovigilance. Describe some of the key pre- and post-market Pharmacovigilance guidance documents that emphasize the benefit: risk profile of drugs/biologics (You can focus on FDA and/or EMA regulations). What do these guidance documents say about benefit: risk? Describe some of the ways in which the benefit: risk profile may change over the course of a new drug/biologic's lifecycle. Feel free to include concrete examples that we have reviewed during the course or an example that you are aware of from your other course or work experience.

Reference no: EM133435677

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