Which regulatory body primarily oversees drug trials within the United States?

The Food and Drug Administration (FDA) primarily oversees drug trials within the United States. This regulatory body is responsible for ensuring the safety, efficacy, and security of drugs, vaccines, and other medical products. The FDA plays a critical role in the clinical trial process by establishing regulations and guidelines for the conduct of these trials, monitoring compliance, and reviewing the data submitted by pharmaceutical companies before a new drug or therapy can be approved for public use.

The agency's authority encompasses not just the approval of drugs but also the enforcement of Good Clinical Practice (GCP) guidelines, which ensure the integrity of clinical trial data and protect the rights and welfare of participants. This oversight is essential in maintaining public trust in the drug approval process and ensuring that the products released to the market are both safe and effective for consumers.

In contrast, while other organizations like the National Institutes of Health (NIH) contribute to clinical research through funding and support, they do not directly regulate drug trials. The Clinical Trials Reporting Program focuses on the transparency and reporting of clinical trials rather than regulating them. Research Ethics Committees, often known as Institutional Review Boards (IRBs), primarily focus on the ethical aspects of clinical trials, ensuring that studies are conducted ethically and that participants' rights are