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Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
Customed, a Puerto Rican maker of convenience packs for surgical procedures, received a U.S. FDA warning letter for unacceptable warehouse conditions and other GMP issues.
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The FDA recently ordered drugmakers in the $1.6 billion testosterone-replacement therapy market to update their labels with warnings of the potential for increased heart attack risks when used for aging-related low testosterone. Read More