Final answer:
The FDA (Food and Drug Administration) is responsible for the approval of new drugs in the United States, involving a thorough process that ensures drug safety and effectiveness but can also lead to patient access delays and financial burdens for companies.
Step-by-step explanation:
The agency responsible for the approval of new drugs in the United States is the Food and Drug Administration (FDA). The FDA is part of the United States Department of Health and Human Services and is charged with ensuring the safety and efficacy of pharmaceutical drugs among other responsibilities. New drugs have to go through a rigorous New Drug Application (NDA) process before they can be sold. This process often takes several years and involves extensive testing in humans to confirm that a drug is safe and effective for its intended use.
While this system protects consumers from the potential harms of unsafe drugs, some might argue that it also leads to losers in the system. These "losers" could be patients who need access to new therapies that are delayed due to the lengthy FDA approval process or companies that incur the high costs and risks associated with drug development under stringent regulations.