Enhancing Regulatory Science for Advancing Pharmaceutical Quality a...
BackgroundFDA regulates pharmaceutical drug products to ensure a continuous supply of high quality drugs in the United States. In regulating the pharmaceutical manufacturing sector, new technologies can improve drug quality, address shortages of medicines, and lower drug costs. To help achieve this, FDA encourages development and adoption of emerging manufacturing technology to modernize pharmaceutical manufacturing. Advanced manufacturing holds great promise for improving the American market for drugs and biologicals and, results in a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance. In other words, encouraging the development and adoption of emerging manufacturing technologies may lead to improved manufacturing, and therefore improved product quality and availability thro...
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