Latest News
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20 February 2013
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US regulators have announced that prescription codeine will now be required to contain a boxed warning contraindicating its use in children who have just undergone a tonsillectomy procedure, saying
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20 February 2013
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"The code is more what you'd call 'guidelines' than actual rules," quipped actor Geoffrey Rush in the 2003 blockbuster, "Pirates of the Caribbean," referring to an oft-broken and morally flexible
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25 October 2012
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The National Institutes of Health (NIH) is preparing to release a new report detailing the therapeutic needs of pediatric patients under the Best Pharmaceuticals for Children Act (BPCA), a piece of
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2 October 2012
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Are the pharmaceutical industry and the National Institutes of Health doing enough to enroll children in clinical trials? No, claims a new study published in the journal Pediatrics and supported by
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Regulatory Update
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21 September 2012
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The European Commission is requesting public comment on its draft report to the European Parliament on the five years of experience since the Pediatric Regulation entered into force in January 2007.
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18 September 2012
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The European Medicines Agency (EMA) is opening a public consultation on a newly released report in which it calls for a new framework to incorporate the views of children into the review of clinical
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Regulatory Update
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20 August 2012
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Australia’s Therapeutic Goods Administration (TGA) has concluded that over-the-counter (OTC) cough and cold medicines registered with the agency should not be given to children under the age of six,
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15 August 2012
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A popular painkiller may put children recovering from surgical procedures at greater risk for serious and potentially fatal side effects, the US Food and Drug Administration (FDA) said Wednesday, 15
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30 July 2012
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The European Medicines Agency (EMA) has announced the publication of a new policy on making changes to pediatric investigation plan (PIP) decisions.PIPs are mandated by Regulation EC 1901/2006, which
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28 June 2012
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A Presidential Commission in charge of studying bioethics wants to know: what are the ethical issues associated with studying medical countermeasures in children?In a 28 June Federal Register posting,
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