Tag Archives: HHS

FDA Details National Vaccine Plan

Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, outlined the importance of the Department of Health and Human Services (HHS) National Vaccine Plan, in a FDA blog on March 11, 2014. Midthun points out how crucial vaccines are in protecting public health and discusses FDA’s role in ensuring a stable supply […]
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"Close Call" for American Rx Marketers on Medicare Part D

As the U.S. heads towards a public market place in which Medicare, Medicaid, CHIPs, VA, and now Obamacare will shortly comprise almost 70% of the American healthcare market, American Rx marketers recently endured a “close call” with the U.S. Department of Health and Human Services over the arbitrary deletion of dozens of key drugs from […]
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Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
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Co-Pay Offset Programs and the New Health Insurance Marketplace: Will the Feds Say No?

By Mark McAndrew. As the health insurance marketplaces begin enrollment this week and go live on January 1, 2014, several issues continue to be a source of significant confusion to manufacturers, payers and the millions of consumers purchasing health insurance for the first time through an exchange.  Many of these issues, such as the cost […]
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Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
Posted in Biotech, compliance, FDA, healthcare, Legal, People, Regulatory, Safety, Strategy | Also tagged , , , , , , , | 1 Comment
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