Put “Spring Cleaning” on Your Summer Compliance To-Do List


Summer can be the time of laid back, restful behavior, but it is also a perfect time to assess your half-year of progress and clean up what needs to be done for the remainder of 2015. While housekeeping can be a chore, breaking the tasks into small steps done on a regular basis can keep you on top of your cleaning game. With ever-closer FDA scrutiny and new guidelines in effect, the cost of drug development has never been higher. According to a recent study by the Tufts Center for the Study of Drug Development, the cost of new prescription medication development through market approval is $2.6 billion. Contract manufacturing organizations (CMO) can polish their activities in the following compliance areas to make sure they pass that white-glove test and keep costs to a minimum:
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FDA Social Media Guidelines in 2015: Engaging with Your Audience on Their Terms


Since the first Food and Drug Administration (FDA) hearings about Social Media in 2009, clarification on proper use and the overall comfort level surrounding the use of social channels for pharmaceutical marketing has been gradual. Now, half-way through the 2010s, marketers and the FDA are facing a new set of marketing technology challenges, driven by the explosion of mobile devices, along with an increasing reliance on responsive web design to proportion web experiences on-the-fly according to screen-size.
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More Stringent Safe Harbor Requirements: The Right Prescription?


Privacy issues raise questions for pharmaceutical companies and the future of cross-border data sharing under the U.S. Department of Commerce’s Safe Harbor program. Rolled out in 2000 between the United States and European Union, the program helps U.S. companies satisfy E.U. data protection laws when receiving personal data from the E.U. Participating companies self-certify that they follow a core set of privacy principles. These principles include the duty to notify users regarding the purpose for which their information is collected and the obligation to provide individuals with an opportunity to opt-out of disclosures to third-parties or uses other than those for which the data was originally collected. Companies also represent that they will secure the personal data. Of the nearly 5,000 U.S. companies that have certified that they abide by the Safe Harbor framework, 238 identify themselves as part of the drugs or pharmaceutical industry.
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