What key authority was enhanced by the Food and Drug Administration Amendments Act of 2007?

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The Food and Drug Administration Amendments Act (FDAAA) of 2007 significantly enhanced the FDA's authority to regulate medication safety. One of the primary goals of the Act was to ensure that the FDA could more effectively monitor and address issues related to the safety of drugs once they are on the market. This included the establishment of a risk evaluation and mitigation strategy (REMS), which requires manufacturers to provide certain safety information and implement measures to mitigate risks associated with their products.

The Act also expanded the FDA's ability to require post-market studies and clinical trials to assess a drug’s safety in real-world populations, as it recognized that adverse effects could emerge after a medication was approved. This focus on drug safety was a critical step in improving public health since it acknowledged that ongoing surveillance of medications is essential to prevent harm to patients.

The other options, while relevant to the FDA's overall role, were not primary enhancements under the FDAAA. Approval of generic medications and mandates for child-resistant packaging are important regulatory aspects but were not the main focus of the Act. Similarly, regulation of drug advertising and promotion, though significant, did not see the level of enhancement that safety regulations did under the FDAAA.

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