The Food and Drug Administration (FDA) plays a pivotal role in the world of clinical trials. As the federal agency responsible for protecting public health, the FDA has the important task of overseeing clinical trials to ensure they are conducted correctly and ethically.
Drug Approval Process
One of the key roles of the FDA in clinical trials is the drug approval process. Before a new drug can be sold to the public, it must first be approved by the FDA. This involves a rigorous review of the results from clinical trials to determine whether the drug is safe and effective. The FDA also reviews the drug’s labeling to ensure that it contains accurate, clear, and useful information for doctors and patients.
Monitoring
In addition to approving new drugs, the FDA also monitors ongoing clinical trials. This involves regular inspections to ensure that the trials are being conducted correctly and that the rights and welfare of the participants are being protected. If any problems are found during these inspections, the FDA can take action to correct them.