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Lessons learned on bona fide service fees and fair market value-is there a 'right answer'?Recent regulatory actions and court cases highlight the importance of due diligence in reporting the value of service fees when federal reimbursements are concerned. The financial consequences can be substantial
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Specialty pharmaceuticals demand integrated patient and prescriber approachesTrue 'market access' should involve coordinated approaches to patients and their healthcare providers
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Finding the value in outsourced contract administrationThe growing complexity of managed-markets contract support makes outsourcing a near-necessity for Small Pharma, and a better option for Big Pharma
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Making Pallets a Supply Chain Asset Instead of an Unrecoverable CostRecent product contamination incidents are highlighting the importance of having reliably clean pallets for warehousing and shipping
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Pacira BioSciences Announces FDA Approval of Expanded Indications for ExparelExparel was initially approved in 2011 for single-dose infiltration into a surgical site.
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Powering up medical affairsTechnology is enabling more resources to reach the medical affairs teams—in a compliant manner
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Storing controlled substances safely and efficientlyGood design of vaults and cages for DEA-regulated materials calls for meeting regulatory requirements while accommodating operational practices
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A 340B Navigation Guide for Pharmaceutical ManufacturersHow drugmakers can navigate the program’s pricing challenges and regulatory developments.
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Life Cycle Management Without BordersTaking a market-by-market approach to maximizing value after loss of exclusivity
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Biosimilars: why deep discounts may become the dominant paradigmEuropean experience to date indicates a changing perspective on biosimilar pricing
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Rethinking Sample DistributionAs the number of specific services associated with sample distribution has grown, so has the number of service providers a manufacturer might use. It’s time to think about consolidating these services
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Oncology Networks Offer Distribution AlternativesThe recent acquisition of US Oncology by McKesson highlights the rising importance of the distributor-led networks
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Maintaining your digital marketing assetsPromotional content produced for, or derived from, digital media presents its own management and compliance complexities
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Specialty pharmaceuticals demand integrated patient and prescriber approachesTrue 'market access' should involve coordinated approaches to patients and their healthcare providers
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Dealing with biologics production uncertaintyThe biologics development and approval process for pharmaceutical companies around the world is typically long and complex, which increases the risk of inaccurately forecasting demand
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OPINION: Will Class-Wide REMS Programs Delay New Opioid Approvals?Class-wide opioid REMS will affect four million patients and require cooperation of more than 25 drug manufacturers
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Managing quality risks across the pharmaceutical supply chainWell designed quality systems follow the product life cycle and foster a culture of quality
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Evidence Generation Is the Foundation to Optimal Product PositioningEvidence Generation Is the Foundation to Optimal Product Positioning
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Collaboration key to a healthy supply chain in 2016HDMA seeks to encourage more outreach to business partners and government
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First physicians, now patients: Risk avoidance in patient support programsA look into the growing compliance risks associated with patient services
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Six Essentials for the Next-Generation Sampling PlatformNew technological capabilities will enable management of sample-distribution processes to keep up with a challenging environment
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The growing role of clinical trial educatorsAddressing patient recruitment and retention issues is a natural role for CTEs
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Industry Revenue Management Practices Are Showing Gradual ImprovementThe 7th Annual Model N survey shows that industry is struggling with the growing complexity of contracts and pricing for managed care and government programs
