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NEWS: Ned Stafford German agency refuses to rule on drug’s benefits until Pfizer discloses all trial results BMJ 2009; 338: b2521 [Full text]

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Government freedom of information provisions and clinical trial data

Malcolm B Gillies   (23 June 2009)

Government freedom of information provisions and clinical trial data 23 June 2009
Malcolm B Gillies, Medical writer Surry Hills, NSW 2010, Australia Send response to journal: Re: Government freedom of information provisions and clinical trial data	Under other circumstances, the data in question might have been available from the FDA. Under the US government freedom of information provisions, the FDA posts extensive details of new drug reviews online, generally with very few 'commercial in confidence' details blacked out. However, the FDA declined the licence application for reboxetine in 2001 and therefore no details of the review were made public. Competing interests: National Prescribing Service is funded by the Australian Government Department of Health and Ageing.