The Food and Drug Administration (FDA) has started a pilot program intended to focus agency resources on imported drugs that do not meet its criteria and thus may pose potential risks of adulteration and misbranding. The Secure Supply Chain Pilot Program will allow successful applicants—foreign manufacturers of finished drug products and active pharmaceutical ingredients—to expedite entry of their products into the United States. Under the pilot, no more than 100 qualified applicants, with no more than 5 drug products per applicant, will be allowed to participate. Those given a “may proceed” designation can increase the likelihood of product entry without human review or examination. See Federal Register, August 20, 2013.
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Supply chain pilot program launched for drug imports
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