The FDA will soon issue a final guidance distinguishing between adverse
events and unanticipated problems in clinical trials, clarifying when
the former have to be reported to an institutional review board (IRB).
The agency also is working with the Health and Human Services' (HHS)
Office for Human Research Protections on a final rule for registering
IRBs.
Mike Leavitt, secretary for the department of Health and Human Services, believes that President George W. Bush’s 10-year plan for
electronic medical records (EMRs) will be accomplished, if not
exceeded, by 2014.
The Canadian Federal Court has dismissed a lawsuit in which Johnson
& Johnson’s Cordis accused Boston Scientific’s NIR stent of
infringing two of Cordis’ Palmaz stent patents.
While FDA enforcement may not be a concern for medical device companies when appealing a warning letter, the agency currently is reviewing its procedures for the appeal and dispute process.
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