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Certain limitations of evidence available on drugs and devices at the time of market approval often persist in the post-marketing period. Often, post-marketing research landscape is fragmented. When regulatory agencies require pharmaceutical and device manufacturers to conduct studies in the post-marketing period, these studies might remain incomplete many years after approval. Even when completed, many post-marketing studies lack meaningful active comparators, have observational designs, and might not collect patient-relevant outcomes. Regulators, in collaboration with the industry and patients, ought to ensure that the key questions unanswered at the time of drug and device approval are resolved in a timely fashion during the post-marketing phase. We propose a set of seven key guiding principles that we believe will provide the necessary incentives for pharmaceutical and device manufacturers to generate comparative data in the post-marketing period. First, regulators (for drugs and devices), notified bodies (for devices in Europe), health technology assessment organisations, and payers should develop customised evidence generation plans, ensuring that future post-approval studies address any limitations of the data available at the time of market entry impacting the benefit-risk profiles of drugs and devices. Second, post-marketing studies should be designed hierarchically: priority should be given to efforts aimed at evaluating a product's net clinical benefit in randomised trials compared with current known effective therapy, whenever possible, to address common decisional dilemmas. Third, post-marketing studies should incorporate active comparators as appropriate. Fourth, use of non-randomised studies for the evaluation of clinical benefit in the post-marketing period should be limited to instances when the magnitude of effect is deemed to be large or when it is possible to reasonably infer the comparative benefits or risks in settings, in which doing a randomised trial is not feasible. Fifth, efficiency of randomised trials should be improved by streamlining patient recruitment and data collection through innovative design elements. Sixth, governments should directly support and facilitate the production of comparative post-marketing data by investing in the development of collaborative research networks and data systems that reduce the complexity, cost, and waste of rigorous post-marketing research efforts. Last, financial incentives and penalties should be developed or more actively reinforced. [ABSTRACT FROM AUTHOR]

The article highlights the accepted posters for the 2014 American Medical Writers Association (AMWA) Annual Conference in Memphis, Tennessee. These include studies on improvement recommendations to the 510(k) program, medical writing strategies for global teams, and a systematic process for creating high-quality developmental strategy update reports.

The article focuses on the approval of the used of whole-slide imaging system for primary diagnosis in Europe and Canada. Topics discussed include challenges on the development of digital pathology such as workflow and technical issues and standardization, the awaiting of approval of U.S. Food and Drug Administration on the use of whole-slide imaging system in the U.S., and the issue of licensure in physicians. Also mentioned are federal medical licensure, federalism, and mutual recognition.

The recall of tens of thousands of defective breast implants in Europe in 2011-12 as well as new data on risks have raised questions about regulatory standards for these and other medical implants in the United States (US) and European Union (EU). In the US, breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in dinical trials and subject to government inspection before they can be sold. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in the EU; approval is based on other information. As a result of these differing standards, the PIP breast implants that were recalled across Europe had been removed from the market years earlier in the US than in the EU, a decision US government health agencies can point to with pride. Nevertheless, the IDA track record on post-marketing breast implant research indicates poorly implemented studies and little meaningful enforcement to ensure that studies have been conducted correctly or findings reported accurately or acted upon. In sum, neither the EU nor the US has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. [ABSTRACT FROM AUTHOR]