Author: Lynne Taylor

Industry warns parliament over “quick and dirty” new drug assessments

A call by UK politicians for all new medicines to be assessed at launch by the National Institute for Health and Clinical Excellence, and at a lower cost-per-quality-adjusted life year (QALY) threshold than the £30,000 which NICE generally sets for a full assessment, does patients a “grave disservice,” an industry spokesman has warned.

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US Congress warned of “gathering storm” at FDA

The US Food and Drug Administration is now “barely hanging on by its fingertips” and the only way to correct this is to double the agency’s funding and raise its staffing levels 50% over the next two years, according to Peter Barton Hutt, senior counsel at the Washington Law firm of Covington & Birling LLP.

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China issues new rules on pharma donations

China has announced new regulations covering pharmaceutical donations from abroad, which include a strict ban on any biological products and any in-hospital preparations, the State Food and Drug Administration has announced.

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US FDA planning to open office in India?

The US Food and Drug Administration is “considering trying to establish” a presence or office in India, US Health and Human Services Secretary Michael Leavitt is reported to have said during his visit to the country with FDA Commissioner Andrew von Eschenbach this month.

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