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Home » GUIDANCES ADDRESS COMBO PRODUCTS, CLINICAL SYSTEMS
GUIDANCES ADDRESS COMBO PRODUCTS, CLINICAL SYSTEMS
October 1, 2004
The FDA last week released its long-awaited final report on the pharmaceutical current good manufacturing practice (cGMP) initiative and while the information package is aimed primarily at drugmakers, it did contain two draft guidances -- one on combination products and another on computerized systems used in clinical trials -- that have a direct bearing on devicemakers.