What is the scope of the FDA’s authority in regulating pharmaceuticals?
The Food and Drug Administration (FDA) is responsible for regulating pharmaceuticals in Washington and the rest of the United States. The FDA has wide-reaching authority over all aspects of the development, production, testing, and marketing of drugs, biologics, and medical devices. The FDA must approve drugs before they can be marketed in the U.S. and also keeps a close eye on manufacturing processes to make sure that drugs and biologics are safe and effective. The FDA also inspects drug manufacturing facilities to make sure they are up to standard. The scope of the FDA’s authority includes monitoring the advertising and labeling of pharmaceuticals to make sure they are accurate and not misleading. The FDA also sets quality standards for pharmaceuticals and is responsible for investigating reports of adverse effects or potential safety risks of drugs and medical devices. They can also require that pharmaceutical companies provide additional safety or efficacy data during the drug approval and post-approval process. All of these regulations and monitoring help the FDA ensure that all medications and medical devices used in the U.S. are safe and effective.
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