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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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US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
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 Subject :US-FDA issues First Draft Guidance on Noninferiority Trials.. 2010-03-04 22:07:46 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Dear Friends,
 
The FDA has proposed the first draft guidance on noninferiority (NI) clinical trials, which may help increase the availability of comparative information on drugs. NI trials compare a new drug with a proven drug to determine whether the new drug is less effective by an unacceptable margin. The major focus of the guidance is determining the NI margin, which must be estimated based on past performance of the active control drug and by comparing other test conditions to the current environment, according to the draft guidance. Comments are due May 30.
 
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