Asked by: Lavona Saguarasked in category: General Last Updated: 12th January, 2020
What is the role of the FDA in drug regulation?
Herein, how does the FDA regulate drugs?
Regulating new drugs The FDA only approves drugs if they are deemed both safe and effective for their intended purpose. The manufacturing plant that produces the drug must pass a rigorous safety inspection and the drug must be labeled correctly, meaning it is prescribed for the conditions it was intended to treat.
Similarly, why is drug regulation important? The regulation of drugs and medicine is crucial to the health and safety of the public. Ensuring that a medicine is high quality is achieved by checking the efficacy, quality and safety of the drug. Regulation is important and followed continuously in every step and process that the drug material passes through.
how much does the FDA regulate?
FDA is responsible for the oversight of more than $2.6 trillion in consumption of food, medical products, and tobacco. FDA-regulated products account for about 20 cents of every dollar spent by U.S. consumers. FDA regulates about 77 percent of the U.S. food supply.
How important is FDA approval?
The FDA's valuable and important role is to conclude whether products are appropriately labeled as determined by risk analysis, assessment, monitoring of approved product clinical studies, evaluation of a company's safety and efficacy claims, and then to grant interstate marketing licenses.