Regulatory Agency Paper
The Food and Drug Administration (FDA) is one of the agencies of the United States Department of Health and Human Services. The FDA is tasked with protecting the public by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation ("FDA Fundamentals", n.d.). The FDA consists of the Office of the Commissioner and four directorates that oversee the centered functions of the agency. The FDA’s core functions oversee medical products, tobacco, foods, global regulatory operations and policy and operations. The FDA reviews and oversees the production of prescription and over the counter drugs to ensure safety to the public. Medical devices are tested and data is reviewed to ensure the safeness of its use before approving the use in patients. The FDA regulates drugs that are used in health care and monitors and collects data regarding the possible risks associated with the use of certain drugs. The FDA can enforce the recall of a drug from being used or restrict its use to limited terms to avoid adverse reactions associated with long term use and the possibility of developing other ailments or symptoms that could be linked to the use of a specific drug. For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. The FDA provides data to clinicians on the possibility of adverse reactions when combining two or more drugs that are prescribed or over the counter (OTC). The use of the OTC drugs are regulated by the FDA on how they are sold and at what dose and may enforce pharmaceutical companies to label drugs with specifics of risks, dangers and possible adverse reactions. The recommended dosage is approved and recommended by the pharmaceuticals with FDA approval. Medical devices implanted in...
Please join StudyMode to read the full document