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    Complex Medicinal Products - the Other 'Biosimilar'

    This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products. Introduction With all the attention recently focused on biosimilars, it might be easy to overlook another group of generics, the complex medicinal products. This group is generally referred to as Non-Biological Complex Drugs (NBCD) and also may be referred to as complex medicinal products. Like biosimilars, NBCDs may...
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    FDA's New Office of Pharmaceutical Quality

    The Center for Drug Evaluation and Research Office of Pharmaceutical Quality (OPQ) was launched in 2015. This article examines FDA's reasons for implementing a major change to oversight of manufacturing quality and the implications for consumers, sponsors and regulatory professionals. The Future of Quality FDA has been and continues to be committed to assuring quality (i.e., safety and efficacy) medicines are available to the American public. FDA implemented quality o...