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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 :Companies to Disclose All Clinical Trials in Patients.. 2009-11-20 17:55:53 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Dear All,
 
The Council of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has approved an updated Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. This extends the range of clinical trials that member companies should provide information on to include all clinical trials in patients, as a minimum. The scope of this new Joint Position will include early stage safety trials of medicines for life-threatening conditions, which are typically not done in healthy volunteers. For the press release click here.
 
Best regards
IP Logged
Last Edited On: 2009-11-20 17:55:53 By GCP HelpDesk for the Reason
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