Drug safety and efficacy data lacking for neonates
January 2nd 2014Despite some key pieces of federal legislation passed in recent years, most drugs-about 93%-are still not studied in neonates. Of those drugs that researchers have studied in this vulnerable population and that bear labels reflecting the changes in pediatric prescribing information, only about half (54%) are used in the neonatal intensive care unit (NICU).
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Stricter bioequivalence rules may be needed for generic antiepilepsy treatments
January 2nd 2014Ongoing studies may lead FDA to stiffen its bioequivalence rules for generic antiepileptic drugs (AEDs) and others with so-called narrow therapeutic indices, according to research presented at American Epilepsy Society (AES) annual meeting recently in Washington, D.C., according to MedPage Today.
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NECC settlement establishes $100 million fund for victims
January 2nd 2014Last week, the New England Compounding Center's owners and insurers agreed to establish a $100 million compensation fund for its creditors, including the victims who were injured after receiving injections of contaminated steroids produced by the now bankrupt NECC. Victims have until Wednesday, January 15 to submit their claims in the case.
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New enrollees in healthcare exchanges to pay more of drug costs
December 20th 2013The newly enrolled individuals to the healthcare exchanges will be faced with higher out-of-pocket costs for their medications than those who receive insurance through their employers, according to an analysis by Avalere Health of more than 600 health plans in the exchanges.
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