Drug Fda Center For Drug Evaluation And Research - 1420 Words

Drug Approval Process - Relevant FDA Centers: The FDA’s Center for Drug Evaluation and Research (CDER), the largest of six FDA centers, plays an essential rule in public safety and health by ensuring that the available drugs in the market are safe and effective for their proposed use. CDER mission is to regulate new drugs, including over-the-counter and prescription treatments, and provide doctors and patients with necessary information to use these drugs wisely and efficiently. CDER, however, is not responsible for testing drugs even though the Center Office of Testing and Research partially investigates areas of the drug quality, safety, and effectiveness. - Investigational New Drug Application (IND): During preclinical drug development, the pharmaceutical company or drug sponsor must determine if the product is viable for human uses. The sponsor must test the new drug on multiple species of animals in vivo and in vitro to assess the drug toxicity and pharmacologic effects. Animal studies could take 2 weeks to 3 months to collect basic information about the safety and efficacy of the drug. The new drug sponsor then submits an Investigational New Drug Application (IND) to FDA based on all data gathered from initial animal testing, including a pharmacological profile of the drug, information about the drug composition and manufacturing, and a plan for the initial phase of clinical trials to test the drug on human without exposing them to unnecessary risks. Additionally,Show MoreRelatedHealth Care Regulatory Agencies Paper889 Words   |  4 Pagesï » ¿ Food and Drug Administration Legal Issues in Healthcare University of Phoenix Health care regulatory agencies supervise professional of the health care profession such as physicians, hospitals, and labs. Providing information in regards to changes in health care along with ensuring the safety and legal compliance and the quality of services provided to the public is the duty assigned to the agency. These agencies can range from the federal, all theRead MoreRegulatory Agency: Food and Drug Administration Essay1617 Words   |  7 PagesAgency: Food and Drug Administration Victoria Steele University of Phoenix Regulatory Agency: Food and Drug Administration The regulation of all areas of health care in The United States falls to The United States Department of Health and Human. One such area is the regulation on medications dispensed within the United States. The section of The United States Department of Health and Human Services responsible for regulation on medications is the Food and Drug Administration (FDA). WhereasRead More FDA Evaluation of Medication Essay1127 Words   |  5 Pages FDA Evaluation of Medication Introduction The main center within the FDA for the evaluation of medication is known as the Center for Drug Evaluation and Research. The center evaluates all drugs before they are sold. 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