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Diabetes Medication Article
FDA's Role in Regulating Insulin
FDA's Center for Drug Evaluation and Research (CDER) oversees drug products, including insulin. CDER makes sure that drugs sold in the U.S. are safe and effective. The center evaluates new types of insulin products, and it regulates the manufacturing, labeling, and advertising of insulin products.
Companies wanting to market insulin products are responsible for testing their products and submitting data showing they are safe and effective. At CDER, teams of doctors, statisticians, and scientists review new drug applications (NDAs). In some cases, FDA seeks help from advisory committees made up of outside experts.
Once a new insulin product is on the market, CDER monitors its quality and makes sure that its manufacturer follows FDA laws and regulations. CDER also monitors insulin products carefully after they are approved to identify any unexpected side effects. Through a system called MedWatch, health professionals and consumers can report serious adverse reactions to any medical product. CDER collects information from MedWatch and the drug industry and conducts statistical evaluations on drug usage, adverse reactions, poisonings, safety, and effectiveness. If necessary, CDER shares information with patients and health professionals.
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