Today, drug manufacturers make many medicines for the U.S. market—including both brand-name and generics—in other countries. To protect patients and consumers, the FDA has programs to address the challenges to drug quality posed by globalization.
Donald D. Ashley, J.D., director of CDER’s Office of Compliance, and Michael Kopcha, Ph.D., R.Ph., director of CDER’s Office of Pharmaceutical Quality, explain the FDA’s work to assure the safety and quality of medicines through strong oversight on a global scale.
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