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Pediatric Trials: The Impact of U.S. Legislative and Regulatory Efforts
The Pediatric Rule made everyone begin to assess, think, and plan for pediatric needs.
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Europeans Weigh-in on Clinical Study Participation
The loss of European competitiveness in the pharmaceutical sector has been widely acknowledged. The European Union (EU) has begun to address this issue through efforts such as the implementation of EU Directive 2001/20/EC, intended to align the EU with international standards for conducting clinical research and to encourage innovation. For example, the directive opens the door to allowing advertising in patient recruitment efforts for clinical research studies, a technique long in use in North America.
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Keeping Approvals on Track
Recent safety issues associated with several blockbuster drugs, such as the Cox-2 inhibitors and antidepressants, have raised tremendous public and governmental concern regarding the safety of drugs and devices on the market. This publicity is naturally creating a more cautious and reactionary environment around the approval of new drugs by the Food and Drug Administration (FDA).
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On-Demand: The Next Generation of Packaging and Labeling
With the increasing number of patient-specific and genetically based medications being developed and the globalization of clinical trials, pharmaceutical and biotechnology companies are facing greater pressures to increase efficiencies in clinical trial material (CTM) management. In particular, there is growing demand on clinical supplies teams to minimize CTM repackaging or overage, shorten packaging and labeling timelines, have the flexibility to customize supplies, and reduce the overall costs associated with CTM management.
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