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On the Cover Sales and marketing compliance As pharmaceutical manufacturers continue to refine and adjust their compliance policies to meet a slew of regulations over the past five years, they also are looking ahead and preparing for regulatory changes that could create many challenges. Features Registering safety As the emphasis on drug development shifts toward improving risk management, new tools have emerged to evaluate safety both pre- and postapproval. Counter measures Switching products from Rx to OTC status can be a viable life-cycle management strategy, one that is expected to be used more frequently. FDA: An agency in transition In the past year, the Food and Drug Administration has achieved momentum in speeding drug development and addressing product safety. But despite progress, the agency will continue to face obstacles in the coming year. Is EDC the next CDMS? Medidata’s Glen de Vries discusses why EDC is the next logical evolution of CDMS. Dr. Barbara DeBuono — A Commitment to Public Health In her position at Pfizer, Dr. Barbara DeBuono is leading the way on vital health-literacy issues, in keeping with Pfizer’s goal of developing holistic health programs. HBA Leadership Conference The 4th Annual HBA Leadership Conference highlighted initiatives to support women’s advancement. Managed Markets: Formularies PBMs and MCOs are now applying their cost-management strategies to high-cost specialty drugs. In Every Issue Letter from the Editor Raise your voice: Letters UpFront A brief review of industry news at press time For Art’s Sake A creative review by the experts PharmaOutlet James Rogers talks about safety and pharmacovigilance in clinical trials. PharmaTrax Sales, marketing, and R&D trends from industry analysts What’s New New healthcare-related products, services, and companies E-Media New electronic and Web-based applications, sites, and technologies On The Calendar Industry events Talent Pool Executive appointments and promotions January 2007 PharmaVOICE Dr. DeBuono is at the forefront of improving health literacy. Robert DeLuccia predicts more scrutiny from the public. William Bertrand believes training is important for ensuring compliance.