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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :EMEA Guidelines on Cystic Fibrosis Drug Development.. 2010-01-05 17:14:16 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear Friends,

The European Medicines Agency (EMEA) first guideline on developing products to treat cystic fibrosis advises drug makers to use forced expiratory volume (FEV) as the primary lung-function endpoint when designing clinical trials for the drugs. A clinically relevant change in FEV should be defined and justified by drug makers, as should the frequency of FEV measurements, according to the final guideline posted on the EMEA’s website last month.

Click here for this guideline

Kind regards,

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