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15.05.2009
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 According to FDA, this guidance is intended to clarify for industry where to include the integrated summary of effectiveness (ISE) and integrated summary of safety (ISS) when...[more]
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15.06.2008
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 This guidance document intends to assist applicants making regulatory submissions to the FDA in electronic format using eCTD specifications. It discusses issues related to...[more]
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03.06.2008
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 The eCTD backbone files for US submissions (index.xml, us-regional.xml) do not contain enough information on the subject matter of several documents (e.g., study report documents)...[more]
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Displaying results 29 to 31 out of 31
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