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Food and Drug Administration, U.S.
U.S. FDA continues to tackle unapproved drugs
November 7th, 2006
The U.S. Food and Drug Administration (FDA) has negotiated a consent decree with one manufacturer of unapproved drugs and sent warning letters to four others. In June, 2006 FDA issued a guidance document, "Marketed Unapproved Drugs - Compliance Policy Guide" (CPG). This CPG makes clear that firms marketing drugs requiring FDA approval must submit applications showing that their products are safe and effective before marketing those products. As part of FDA's ongoing effort against marketed unapproved drugs and consistent with the CPG, FDA announced that Syntho Pharmaceuticals, Inc., and Intermax Pharmaceuticals, Inc. (Syntho/Intermax), of...
Source: Drug Law Weekly (2006-11-07)
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