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CDER guidance for generics offers some help to OTC drug makers, but FDA may incorporate guidance in monographs.(Impurities): An article from: Validation Times
Melissa Winn
Washington Information Source, Inc.
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Inspectors focus on process design and implementation under ICH guidelines.: An article from: Inspection Monitor
Melissa A. Winn
Washington Information Source, Inc.
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FDA to start enforcing labeling requirements for OTC drug products Sept. 30.(Labeling): An article from: Validation Times
Melissa A. Winn
Washington Information Source, Inc.
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