Rems fda history biography

On September 27, 2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), further amending the Food, Drug, and Cosmetic Act.

The FDAAA authorizes the Food and Drug Administration (FDA) to require risk evaluation and mitigation strategies (REMS) on medications if necessary to minimize the risks associated with some drugs.

The FDA has a responsibility to ensure that the benefits of a medication outweigh the potential risks of that medication.

To determine this, the FDA looks at the seriousness of the disease or condition to be treated, size of the patient population, expected benefit of the drug, expected duration of treatment, and seriousness of the known or potential adverse events.

Rems fda history biography

If a medication's benefits outweigh the risks associated with it, the FDA approves it. Sometimes though, the medication therapy itself still carries a lot of risks with it. In that situation, the FDA may