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The agency followed up with an announcement in the Federal Register today, announcing that it is issuing "guidance" to companies that produce in vitro diagnostic products labeled "for research use only" and "for investigational use only".
*Update, 25 November, 7 30 p.m.: This article was updated to clarify that FDA has issued guidance to companies that produce in vitro diagnostic products labeled "for research use only" and "for investigational use only," not an announcement of proposed regulation.
MagnaStim for sale, labeled as 'For Investigational Use Only', end of Year Two.
Regulatory Issues Through obtaining an Investigational Device Exemption and clearly labeling the product "For Investigational Use Only," FDA regulations will be satisfied and market entrance will be expedited.
However, Spierings et al. still consider resurfacing as an experimental design for investigational use only, until long-term follow up confirms its superiority in comparison with total hip replacement [ 3, 4].
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All materials were approved for investigational-use only.
The immunohistochemical staining method used followed the standardised protocol supplied by DAKO (Glostrup, Denmark) for the investigational-use-only pre-prototype test reagent specific for TRAIL-R1 (Humphreys and Halpern, 2008).
For the time being the detection of CK-19 CTCs as a marker for therapeutic decision making in patients with early breast cancer should be considered investigational and used only in the context of clinical trials.
Neither drug is approved by Food and Drug Administration, but both are available under investigational use protocols (Centers for Disease Control and Prevention Drug Service).
Limited by Federal Law to Investigational Use.
The investigational use of nonhuman primates has long been a contentious issue.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com