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FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based Approach
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Representatives of the US Food and Drug Administration and Industry
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The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.
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Approved Applications of Dimethyl Sulfoxide USP, PhEur
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A.S. McKim
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Robert Strub
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The authors survey the approved applications of dimethyl sulfoxide USP, PhEur across the healthcare industry and consider the suitability of DMSO from a regulatory and formulation compatibility standpoint.
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EPCAM: Enabling Manufacturing-Process Control Transformation
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James M. Prendergast
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Michael Passow
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Michael T. Ricci
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Srinivas S. Dagalur
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Dennis Bell
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Limuel Sagadraca
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Enterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
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Attacks on FDA Escalate
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Jill Wechsler
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Regulators face demands to improve postmarket surveillance and meet review deadlines.
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Troubled Waters
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Control, a senior compliance officer
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WFI system deficiencies and damp tax records cause problems for two plants
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Requiem for a Vaccine
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Michelle Hoffman
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Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.
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PharmTech Talk
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Erik Greb
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INTERPHEX 2008 offered visitors novel experiences and many stimulating sessions.
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Report from Europe
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Sean Milmo
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With counterfeiting on the rise and Europeans worried their backyard is becoming a base for such illegal activity, legislators have proposed a series of solutions that span the continent and abroad.
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Market Watch: Japan
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Angie Drakulich
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According to the latest figures from IMS Health, Inc., Japan's pharmaceutical market is expected to grow 1–2% this year compared to global industry growth expectations of 5–6%.
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In the Spotlight
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Editors' Picks of Pharmaceutical Science & Technology Innovations
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